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

Model Number	8888412007
Medical Device Problem Codes	Defective Component (2292); Detachment of Device or Device Component (2907)
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	04/03/2018
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.
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 tobe fractured.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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led no evaluation because no photographic image of a device was received.Without a photograph or physical product post market vigilance cannot reliably determine the reported condition.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.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.It was stated that the catheter was seen fractured.The catheter was not replaced completely and they just cut off a section of the tube which had problems.The catheter was connected again after disinfection.The location of the problem was not in the body, but in vitro.There was no patient injury.

• 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: 7714663
• Report Number: 3009211636-2018-00248
• Device Sequence Number: 1329053
• 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,Followup
• Report Date (Section B): 10/23/2018

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; 09/28/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 09/05/2018; 10/03/2018; 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1