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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of reze1532 showed no other similar product complaint(s) from this lot number.
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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 knotted catheter was confirmed but the cause remains unknown.The product returned for evaluation was one 4fr single-lumen powerpicc solo catheter.Usage residue was observed throughout the catheter.A knot in the catheter material was observed at the 45cm depth marking.Tactile evaluation of the sample confirmed a knot in the catheter with slight tensile weakness throughout.Microscopic examination of the sample revealed no manufacturing defects or deformities in the catheter material.No evidence was found on the sample that would have contributed to the knotting of the catheter.Although the cause of this event is unknown, the knotted region may be related to insertion technique.This can occur by moving the catheter forward, twisting it, and then retracting it, all through a tortuous path.No further action is required because the complainant event could not be related to a deficiency in product manufacture or deficiency while under correct product use.
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