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 of separation of the deployment device housing was inconclusive due to the sample condition.A series of six photographs of a powerglide pro deployment device and catheter were returned for evaluation.Only the distal end of the deployment device and part of the catheter were within the frame of the photographs.The top and bottom pieces of the deployment device housing were starting to separate, and the catheter was seen protruding from the side of the deployment device.The guidewire was not seen protruding from the distal end of the catheter and the guidewire push-off button did not appear to be in the fully advanced location.The housing is designed to separate as the catheter is advanced to allow for passage of the luer adaptor and wings off of the deployment device.It could not be determined from the photographs if the insertion sequence was followed or if the housing separated prematurely during the procedure.Without functional testing of the physical device, it could not be determined if the device failed to perform as intended.However, the report of a difficult insertion has been documented and included in complaint trending as part of ongoing efforts to identify potential issues.H3 other text : evaluation findings are in section h.11.
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