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: 11/2022).
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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; however, one electronic photo was provided for review.The photo shows one hemosplit dialysis catheter implanted in a patient body.Both the extension legs of the catheter was found bulged.The arterial extension leg was noted to have a bulge and opacified proximal to the bifurcation.Slight opacification was noted on the venous extension leg proximal to the bifurcation.Yellowish color was noted throughout the catheter.Therefore, the investigation is confirmed for the reported material opacification, material protrusion and stretched issues.A definitive root cause for the reported failure could not be determined based upon the provided 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.H10: d4(expiry date: 11/2022), g3, h(method) 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.H3 other text : device not returned.
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