As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.(expiration date: 03/2022).
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H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical sample was not returned for evaluation, one electronic photo was provided for review.The photo shows one 24cm hemostar dialysis catheter implanted in a patient chest.Emulsification of catheter was found on both the extension legs of the catheter proximal to the bifurcation.Both the extension legs were found deformed just proximal to the bifurcation.Residues were noted throughout the catheter.Therefore, the investigation is confirmed for the reported material opacification and identified material protrusion 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: 03/2022).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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