It was reported the connection between the catheter and the catheter cone is broken before use.During the midline placement, when the nurse went to check the catheter permeability, she found that it was leaking from the connection between the catheter and the cone of the catheter.No other information was provided.
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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, applicable previous investigation(s), sample analysis, manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking midline catheter was confirmed; however, the root cause was not identified.The product returned for evaluation was two photographs and one segment of digital video which depicted a 4fr d/l powermidline midline catheter.Both photographs and the video depicted the molded joint and a section of catheter shaft.The catheter shaft appeared to have been cut between the 2cm and 3cm depth markings.In both photographs and in the video, the sample was being flushed.Clear infusate was visible leaking at the molded joint/catheter joint.Leakage was evident in the submitted photographs and video; however, inspection of those articles was insufficient to identify the cause of the leakage.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include material fatigue and sharp instrument contact.
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It was reported the connection between the catheter and the catheter cone is broken before use.During the midline placement, when the nurse went to check the catheter permeability, she found that it was leaking from the connection between the catheter and the cone of the catheter.No other information was provided.
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