The information provided by bard 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 bard.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a damaged catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 20ga x 2.25¿ accucath catheter.Blood residue was evident within the catheter tube.The sample was received in two segments which shared a complete break approximately 2cm distal of the molded joint.Multiple kinks were apparent along the length of the distal fragment.The break appeared irregular.Elongation and curved shape memory were evident in the vicinity of the break.Microscopic inspection of the break confirmed extensive deformation/elongation.The break surface was partially granular and partially striated.The striated region exhibited a tapered profile.Inspection of the tip of the catheter revealed deformation.The catheter fracture features were consistent with damage that was initiated by contact between the catheter and the needle tip and propagated by tensile (pulling) stress.The abundant kinks and catheter tip damage suggested possible difficulty experienced during catheter insertion/guidewire retraction.The product ifu states ¿warning: do not force or retract the guidewire.¿ and ¿warning: once the catheter has been advanced, do not re-insert the needle back into the catheter or pull the catheter back onto the needle.If the catheter needs to be repositioned, either do so without the aid of the needle, or remove both the catheter and the needle as a unit to prevent the needle from damaging or shearing the catheter.¿ a lot history review (lhr) of recn0849 showed no other similar product complaint(s) from this lot number.(b)(4).
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