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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of safety mechanism failure to activate was confirmed and the cause appeared to be manufacturing-related.The product returned for evaluation was one 22ga x 0.75¿ huber plus safety infusion set.Usage residues were observed throughout the sample.The safety mechanism was not engaged.Attempts to activate the safety mechanism were unsuccessful.The safety was not mobile on the needle shaft.Microscopic inspection of the safety mechanism revealed adhesive residues bonding the safety to the needle shaft.The safety mechanism failure was caused by adhesive which appeared to have been deposited during device assembly.Photographs of the sample have been forwarded to the manufacturing site for further evaluation.H3 other text : evaluation findings are in section h.11.
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