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

Model Number	8888412007
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2018
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, after tube placement for home treatment, the peritoneal dialysis catheter was found thinner than before.The doctor described the tube's wall became thin and crisp, easily broken or broken or suspected to be fractured, and part of them were directly disconnected.It was stated that the patient found the device had leaked and then went to the hospital.The doctor also found the leakage during the checking.It was also 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 patient due to injury caused by the product and feedback from the hospital.

• 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: 8144558
• Report Number: 3009211636-2018-00385
• Device Sequence Number: 1624429
• 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,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/07/2018

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1