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 catheter was confirmed.The product returned for evaluation was one 22ga x 8cm powerglide pro midline catheter assembly.The catheter had been advanced and the safety mechanism was engaged over the needle tip.The catheter shaft exhibited a complete break dust distal of the molded joint.The distal catheter fragment was not returned for evaluation.The break site appeared irregular.Microscopic inspection of the break site revealed a partially glossy and partially dully granular fracture surface.The break exhibited a tapered profile.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.
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