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 midline was confirmed.The product returned for evaluation was one 20ga x 10cm powerglide pro midline catheter.The catheter was removed from the insertion assembly and the assembly was not returned for evaluation.The catheter terminated 7.8cm from the molded joint.The distal fragment was not returned for evaluation.Microscopic inspection of the break site revealed a partially glossy and partially dully granular fracture surface.The break exhibited a tapered profile.A longitudinally aligned scoring mark was observed on the inside surface of the catheter leading into the fracture site.The break features were consistent with the catheter being damaged by contact with the introducer needle tip.Such damage can occur if the catheter is pulled back onto the needle and if the needle is re-inserted following catheter advancement.A lot history review (lhr) of regt2103 showed no other similar product complaint(s) from this lot number.
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