MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PERITONEAL; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number	8888412007
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during use, the peritoneal dialysis catheter was disconnected at the titanium joint junction.It was also stated that the device had a leak at the titanium connector.It was reported that there were many cases where the catheter was disconnected at the titanium joint junction.These cases were noted from different batches and different patients.There was no patient injury.
Additional Manufacturer Narrative
The incident device has been received and is under evaluation.When the device evaluation is complete a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during use, the peritoneal dialysis catheter was disconnected at the titanium joint junction.It was also stated that the device had a leak at the titanium connector.The doctor and nurse indicated that the issue was caused by the peritoneal dialysis catheter pipe wall becoming thin and brittle.It was also stated that they opened the titanium joint and removed the disconnected part or cut the leaking part to resolve the issue.The rest of the catheter was reconnected inside the titanium joint.The catheter has been in place for 6-12 months.The connector was tightened by hands and pliers.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted that the device was received in nine (9) pieces in eight (8) sample bags.The condition in which the device was received precludes functional testing.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Replication of the cut-up tubing may occur when mishandled during clinical application.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: PERITONEAL
• Common Device Name: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 7669485
• Report Number: 3009211636-2018-00231
• Device Sequence Number: 16496276
• Product Code: FJS
• UDI-Device Identifier: 10884521004375
• UDI-Public: 10884521004375
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K862046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8888412007
• Device Catalogue Number: 8888412007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Initial Date Received by Manufacturer: 06/22/2018
• Supplement Date Received by Manufacturer: 07/11/2018; 08/28/2018; 08/08/2018; 08/08/2018
• Initial Report FDA Received Date: 07/09/2018
• Supplement Report FDA Received Date: 08/06/2018; 09/17/2018; 10/03/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR