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

Model Number	8810888003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/26/2019
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, prior to use, the device had a crack in the tube.There was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted: only a four (4) inch piece of catheter tube was received in a small sample jar.Functional testing: functional testing would normally include leak testing however the tube was cut precluding this type of testing.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the cut catheter shaft may occur when contact is made with a sharp surgical instrument during clinical application.The root cause of the observed damage was found to be due to the device not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARGYLE
• 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: 9132265
• Report Number: 3009211636-2019-00209
• Device Sequence Number: 14066494
• Product Code: FJS
• UDI-Device Identifier: 10884521004047
• UDI-Public: 10884521004047
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K890288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2020

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: 8810888003
• Device Catalogue Number: 8810888003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1