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, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged catheter is confirmed and was determined to be use related.One 4 fr single lumen groshong nxt clearvue catheter with stiffening stylet and flushing hub inserted was returned for evaluation.An initial visual observation showed use residue on the returned sample.A hole was observed in the catheter approximately 2.3 cm proximal to the distal tip of the catheter.A microscopic observation revealed a ¿c¿-shaped split in the catheter just proximal to the distal tip of the stylet within the catheter.The surface of the split was observed to be granular in texture.The location, shape, and texture of the damage observed in the returned catheter are indicative of damage caused by the stylet tip; this can be caused by manipulation of the stiffening stylet within the catheter without first flushing the catheter and/or forceful insertion of the stylet and catheter against resistance.A lot history review (lhr) of recv3447 showed no other similar product complaint(s) from this lot number.
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