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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, HEMODIALYSIS, IMPLANTED

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COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, HEMODIALYSIS, IMPLANTED Back to Search Results
Model Number 8888145251
Device Problem Hole In Material (1293)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/12/2017
Event Type  malfunction  
Manufacturer Narrative
Submit date: 2017-july-11.The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported to covidien on 2017/june/20 that a customer had an issue with a dialysis catheter.The customer states there is a hole in the extension tube.
 
Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted that the tube and connector were covered with dried blood.The tube past the connector had dried blood inside.A visible hole was not identified.Pmv could not perform functional testing due the dried blood blocking the tube.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Replication of the dried blood blocking the tube may occur when mishandled during clinical application.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.If information is provided in the future, a supplemental report will be issued.
 
Event Description
The customer states there is a hole in the extension tube close to the insertion site.The catheter was removed and replaced.
 
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Brand Name
MAHURKAR
Type of Device
CATHETER, HEMODIALYSIS, IMPLANTED
Manufacturer (Section D)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 0101
Manufacturer (Section G)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 0101
Manufacturer Contact
lisa hernandez
15 hampshire street
mansfield, MA 02048
2034925563
MDR Report Key6700195
MDR Text Key79646285
Report Number3009211636-2017-05224
Device Sequence Number1
Product Code MSD
UDI-Device Identifier10884521014220
UDI-Public10884521014220
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/27/2018
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
Device Operator Health Professional
Device Expiration Date10/13/2020
Device Model Number8888145251
Device Catalogue Number8888145251
Device Lot Number1531600079
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2018
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/20/2017
Initial Date FDA Received07/11/2017
Supplement Dates Manufacturer Received08/09/2018
Supplement Dates FDA Received08/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/13/2015
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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