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: one guidewire was returned for evaluation.Gross visual, dimensional, microscopic evaluations were performed on the returned device.Uncoiling was noted throughout the distal end of the guidewire.The flat core wire was noted to have the complete break.Therefore, the investigation is confirmed for the identified fracture, material separation and stretched issues.However, the investigation is inconclusive for the reported physical resistance and difficult to insert issues as the exact circumstance at the time of the event reported was unknown.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiry date: 01/2025).H11: section a through f ¿ the information provided by bd represents all 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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