As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 07/2022).
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H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical sample was not returned for evaluation, one electronic photo was provided for review.The investigation is confirmed for the reported catheter emulsification, discoloration, material protrusion and stretched issues as, clamps were noted to be discolored on the extension legs.Further, one of the extension leg was noted to be emulsified and bulged.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.The current instruction for use states.Warning: acetone and polyethylene glycol (peg)-containing ointments can cause failure of this device and should not be used with polyurethane catheters.Chlorhexidine patches or bacitracin zinc ointments (e.G., polysporin ointment) are the preferred alternative.Alcohol or alcohol-containing antiseptics (such as chlorhexidine) may be used to clean the catheter/skin site; however, care should be taken to avoid prolonged or excessive contact with the solution(s).Solutions should be allowed to completely dry before applying dressing.Warning: alcohol should not be used to lock, soak or declot polyurethane dialysis catheters because alcohol is known to degrade polyurethane catheters over time with repeated and prolonged exposure.Care and maintenance: the care and maintenance of the catheter requires well trained, skilled personnel following a detailed protocol.The protocol should include a directive that the catheter is not to be used for any purpose other than the prescribed therapy.Exit site cleaning: povidone iodine, dilute aqueous sodium hypochlorite solution, chlorhexidine gluconate 4%, or chlorhexidine gluconate 2% solution are the suggested antiseptics to use.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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