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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. ARGYLE; CATHETER, PERITONEAL, LONG-TERM INDWELLING
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COVIDIEN MFG SOLUTIONS S.A. ARGYLE; CATHETER, PERITONEAL, LONG-TERM INDWELLING Back to Search Results
Model Number 8888413815
Medical Device Problem Code Migration or Expulsion of Device (1395)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 05/29/2020
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 not working and was not adequately draining the dialysate.The catheter¿s coil moved.It was stated that catheter was repositioned.It was also stated that the catheter did not break.There was no reported patient outcome.
 
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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
CS  20101
MDR Report Key11942355
Report Number3009211636-2021-00129
Device Sequence Number3755133
Product Code FJS
UDI-Device Identifier10884521004627
UDI-Public10884521004627
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K180485
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/04/2021
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 Number8888413815
Device Catalogue Number8888413815
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/13/2021
Initial Report FDA Received Date06/04/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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