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 a damaged powerglide pro catheter was inconclusive because the implicated component of the device was not returned.The product returned for evaluation was one 20ga powerglide pro midline catheter placement assembly.Usage residues were observed throughout the sample.The guidewire was fully advanced and intact.The catheter had been advanced and the safety mechanism was in place over the needle tip.The implicated catheter was not returned for evaluation.Microscopic inspection of the sample was unremarkable.No deficiencies were discovered during evaluation of the returned sample; however, the implicated catheter was not returned with the placement assembly.Consequently this complaint is inconclusive at this time.
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