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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 8817278006
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, there was found to be catheter leakage during servicing of the device.It was noted that the catheter was not repaired and there was no luer adapter issue.There was no reported patient outcome.
 
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Brand Name
ARGYLE
Type of Device
CATHETER, PERITONEAL, LONG-TERM INDWELLING
Manufacturer (Section D)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
Manufacturer (Section G)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
Manufacturer Contact
lisa hernandez
15 hampshire st.
mansfield, MA 02048
2034925563
MDR Report Key9446677
MDR Text Key180461639
Report Number3009211636-2019-00264
Device Sequence Number1
Product Code FJS
UDI-Device Identifier10884521004252
UDI-Public10884521004252
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K890288
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/11/2024
Device Model Number8817278006
Device Catalogue Number8817278006
Device Lot Number1912600115
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/25/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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