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, applicable previous investigation(s), sample analysis, review of manufacture production records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a kinked catheter/difficult connector assembly was confirmed.The product returned for evaluation was one 4fr s/l groshong catheter.The catheter was received partially assembled with a two-piece connector.Approximately 4cm of catheter shaft were returned.The distal portion was inserted into the distal connector segment.The proximal end overlaid the connector cannula.The catheter was bunched at the base of the cannula.Microscopic inspection of the catheter confirmed that it was bunched against the grey plastic at the base of the cannula.Permanent kink impressions were observed near the proximal end of the catheter segment.Microscopic inspection of the connector revealed deformation within the locking regions of both segments.Following longitudinal bisection of the distal connector segment, inspection of the compression sleeve revealed that it had been advanced.The catheter bunching and kinking and reported connection difficulty appeared to be caused by inserting the catheter too far onto the metal connecter cannula during catheter/connector assembly.Such damage can be avoided by ensuring that the catheter lies flat and smooth on the connector cannula prior to connector assembly.The connector deformation was consistent with forceful disassembly of the connector, as indicated in the event description.H3 other text : evaluation findings are in section h.11.
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