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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PERMCATH; CATHETER, SUBCLAVIAN
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COVIDIEN MFG SOLUTIONS S.A. PERMCATH; CATHETER, SUBCLAVIAN Back to Search Results
Model Number 8834369001
Medical Device Problem Code Occlusion Within Device (1423)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/28/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product event summary #does not meet reporting criteria.Hence not reportable in (b)(6).If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during the procedure, the catheter could not pass through the pull apart sheet or flow guard.There was no reported patient injury.
 
Additional Manufacturer Narrative
This event has been reassessed and found to be a non-mdr reportable complaint.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
PERMCATH
Common Device Name
CATHETER, SUBCLAVIAN
Manufacturer (Section D)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
MDR Report Key7597214
Report Number3009211636-2018-00201
Device Sequence Number16187682
Product Code LFJ
UDI-Device Identifier10884521009905
UDI-Public10884521009905
Combination Product (Y/N)N
Initial Reporter CountryIN
PMA/510(K) Number
K871942
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date (Section B) 06/27/2018
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 Expiration Date06/22/2021
Device Model Number8834369001
Device Catalogue Number8834369001
Device Lot Number1619500110
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/29/2018
Supplement Date Received by Manufacturer05/29/2018
Initial Report FDA Received Date06/13/2018
Supplement Report FDA Received Date06/27/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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