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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 8815677001
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Peritonitis (2252)
Date of Event 07/19/2020
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 had a split (like a cut) where the adapter connects the transfer set to the patient side which was noticed due to a leak noted by the patient's parent.The catheter was repaired.The patient developed peritonitis and was admitted to the hospital for two weeks.The patient required antibiotics.
 
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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 Key10875383
Report Number3009211636-2020-00286
Device Sequence Number4001976
Product Code FJS
UDI-Device Identifier10884521004207
UDI-Public10884521004207
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K180485
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign,user faci
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/20/2020
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 Number8815677001
Device Catalogue Number8815677001
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/30/2020
Initial Report FDA Received Date11/20/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Other;
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