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.The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), applicable manufacturing records, photo analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint that the safety mechanism would not engage was inconclusive due to the sample condition.A photograph of the implicated 2.25¿ x 20g accucath ace intravascular catheter deployment device was returned for evaluation of this complaint.The catheter had been fully advanced off of the deployment device prior to the photograph being taken.It appeared that the guidewire slider was in the advanced position and the guidewire was seen extending out of the distal end of the needle cannula.The needle cannula and proximal end of the guidewire had not been retracted into the safety chamber.No obvious damage was visible to the guidewire, needle, or safety mechanism button.Without the receipt of the physical sample, functional testing could not be conducted on the device.The observable features on the submitted photograph did not contain enough information to confirm the complaint nor identify a specific root cause of the reported event.Possible contributing factors could include damage to the needle bevel causing the guidewire to snag during activation, a bent or bowed needle cannula, damage to the spring, improper interference between components, or not advancing the catheter far enough prior to attempting safety mechanism activation.A review of the manufacture quality and inspection records for the specific lot involved found no potentially related issues encountered during the manufacture and assembly of that product lot.The complaint of difficulty activating the safety mechanism has been documented and included in complaint trending.This type of complaint will continue to be monitored as part of ongoing efforts to identify any potential manufacturing related issues.H3 other text : evaluation findings are in section h.11.
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