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

Model Number	8888414011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/13/2018
Type of Reportable Event	Serious Injury
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 catheter would fill dialysate, but would not drain.The patient was sent in for repair, but the catheter broke off and was found floating in the abdomen.The catheter was removed laparoscopically and it was replaced with a new lower peritoneal dialysis (pd) catheter.

• 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: 7464642
• Report Number: 3009211636-2018-00130
• Device Sequence Number: 16169290
• Product Code: FJS
• UDI-Device Identifier: 10884521004665
• UDI-Public: 10884521004665
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K950042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8888414011
• Device Catalogue Number: 8888414011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Weight: 102