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

Model Number	8888410506
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2018
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, during use, there was leak found near the titanium adapter.There was no reported patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led a photographic evaluation of two photographs of device.The visual inspection noted: the first photo depicts fluid in the cannula near the titanium adapter.It¿s not clear if there is a hole or an air bubble.The second photo depicts a different angle view.It¿s not clear if there is a hole or possible air bubble.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.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: 7953139
• Report Number: 3009211636-2018-00320
• Device Sequence Number: 1311671
• Product Code: FJS
• UDI-Device Identifier: 10884521004306
• UDI-Public: 10884521004306
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K862046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2018

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: 8888410506
• Device Catalogue Number: 8888410506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Initial Date Received by Manufacturer: 09/13/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 12/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Weight: 22