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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: one powerport implantable port, one 8.0fr peel-apart sheath, one vessel dilator, one vein pick, one right-angle non-coring needle, one cath-lock, one tunneler, one cath-lock and one catheter stylet loaded to a groshong catheter, one guidewire hoop, one introducer needle and guidewire straighter loaded to a guidewire and one unsealed safety infusion set was received for evaluation.Visual, microscopic, dimensional and functional evaluations were performed.The uncoiled and stretched guidewire was noted to be stuck within the introducer needle.The flat core wire was noted to have a complete break and protruding from the guidewire.The round core wire was noted to have a complete break within the coils of the guidewire.The distal portion of the j-tip guidewire was noted to be uncoiled.Therefore, the investigation is confirmed for the reported physical resistance and identified stretched, unraveled and fracture issues.However, the investigation is inconclusive for the reported failure to advance issue as the exact circumstance at the time of the event reported was unknown.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.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 (expiration date: 09/2025) 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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