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 leaking infusion set was confirmed.The product returned for evaluation was one 20ga x 0.75¿ safestep safety infusion set.Usage residues were observed throughout the sample and the safety mechanism was engaged.A needleless injection cap was attached to the luer adapter.A partially circumferential split was observed at the luer/tubing joint.Microscopic inspection of the split revealed a dully granular fracture surface.Beach marks and radiating tear marks were observed throughout the fracture surface.Deformation and discoloration were observed in the vicinity of the split.The fracture features were consistent with material fatigue, suggesting that damage was accumulated through repetitive mechanical stresses such as twisting and bending; however, an additional factor(s) may have contributed.The device is a supplied component and the supplier has been notified of this event.
|