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); No Information (3190)
Date of Event	05/22/2018
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, the peritoneal dialysis catheter was disconnected at the titanium joint junction.It was also stated that an abnormality was found on the broken pipe wall and the wall of the tube was thinner than before.The catheter was implanted.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, after tube placement for home treatment, the peritoneal dialysis catheter was disconnected at the titanium joint junction.The doctor described the tube's wall became thin and crisp, easily broken or broken or suspected to be fractured, part of them were directly disconnected.It was stated that the catheter was not replaced completely and they just cut off a section of the tube which had problems then, after disinfection the catheter was connected again.The location of the problem was not in the body, but in vitro.Customer reported no complaints were received from the patients due to injury caused by the products and feedback from the hospital.
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: 7713584
• Report Number: 3009211636-2018-00241
• Device Sequence Number: 903891
• 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: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,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?: No
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 08/17/2018; 08/08/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 09/05/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1