ORTHO BLISS 의 안전성 경고

Safety alert

2014-06-24

2014-06-24

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140624b.html

Medical device safety alert: ortho-clinical diagnostics ortho bliss medical device manufacturer, ortho-clinical diagnostics, has issued a medical device safety alert concerning its ortho bliss [product code: 707116; lot no.: 280397; quantity 4 x 50ml; expiry date: 06 aug 2015] due to the presence of mold particles (cladosporium species) in unopened vials of ortho bliss, lot 280397. during a routine internal inspection, the manufacturer observed mold-like particles in four vials of ortho bliss, lot 280397, out of a total of 2400 vials (0.17%) that were inspected. testing performed by millipore (uk) ltd., the contract manufacturer, confirmed the presence of mold (cladosporium species) in these four vials of ortho bliss vials, lot 280397. testing conducted by millipore (uk) ltd. confirmed that vials of ortho bliss, lot 280397 containing mold continued to meet product performance specifications for potency, specificity, ph, conductivity, and osmolality. according to the manufacturer, previously reported results obtained with ortho bliss, lot 280397 are acceptable, provided that the expected results were obtained during quality control testing. affected users can continue using the current inventory of ortho bliss, lot 280397 until they receive replacement products. results are acceptable, provided that they follow the ortho bliss instructions for use, specifically: visually inspect all vials of ortho bliss prior to use. the ortho bliss instructions for use cautions against using the product if it is turbid or discolored. perform quality control testing on each day of use. patient results are acceptable, provided that the expected results were obtained during quality control testing upon receipt of the replacement products, affected users should discontinue using and discard all remaining vials of ortho bliss, lot 280397. possible health hazards include rectal damage (necrosis/ perforation/ulceration or bleeding), expulsion of the device and/or leakage, fecal soiling of bed linen/incontinence pads leading to skin deterioration around the anus, peeling skin, and raw, irritated lesions due to skin contact with fecal matter. death may also occur. the manufacturer advises users to stop using and return the affected devices. for details, please refer to the fda websites according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 24 jun 2014.