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 the catheter tubing separating from the luer connector was confirmed; however, the root cause of the event was not identified.The product returned for evaluation was one photograph depicting an 18ga x 10cm powerglide pro midline catheter.Usage residues were observed on the depicted sample.An extension set was attached to the luer adapter.The catheter was completely separated from the luer adapter.It could not be determined from the photograph if the catheter tubing was detached or broken.While device damage was evident in the submitted photograph, inspection of that photograph was insufficient to identify the cause of the damage.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.The length of time between device placement and catheter separation suggested that use conditions may have contributed to the event.Potential contributing factors include sharp instrument contact, material fatigue and tensile (pulling) stress.A lot history review (lhr) of recx2679 showed no other similar product complaint(s) from this lot number.
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