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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 8888413823
Medical Device Problem Code Infusion or Flow Problem (2964)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
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, it was stated that the patient had a drainage problem due to the catheter.The caregivers prescribed a fluctuating modality to the patient in order to alleviate these drainage problems.It was stated that the lines are not pinched, stuck or blocked and was in the right place of the abdomen.There was no patient injury.
 
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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 Key11331418
Report Number3009211636-2021-00041
Device Sequence Number14298691
Product Code FJS
UDI-Device Identifier10884521004634
UDI-Public10884521004634
Combination Product (Y/N)N
Initial Reporter CountryFR
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) 02/16/2021
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 Number8888413823
Device Catalogue Number8888413823
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/22/2021
Initial Report FDA Received Date02/16/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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