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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 05/09/2017
Event Type  malfunction  
Manufacturer Narrative
Submit date: 2017/july/03.An investigation is currently underway; upon completion the results will be forwarded.
 
Event Description
It was reported to covidien on (b)(6) 2017 that a customer had an issue with a dialysis catheter.The customer states there was a hole in the venous extension.The catheter was repaired and remains in use.
 
Manufacturer Narrative
A device history record (dhr) review revealed no discrepancies that may have contributed to a complaint of this failure mode.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met specification requirements.In addition, all dhrs are reviewed for accuracy prior to product release.The actual sample involved in the reported incident was not returned for evaluation.No additional information, pictures or videos were received.Consequently, it was not possible to evaluate it as part of a comprehensive failure investigation.No probable cause was found since no sample, picture or video were received for testing.The reported condition is not confirmed.If the sample is returned in the future, this complaint will be re-opened for further investigation.No trends or triggers have been found.Therefore, a corrective and preventive action (capa) is not deemed necessary at this time.It must be noted that in-process controls, such as personnel training, incoming quality acceptance testing for (b)(4) 100% in process visual inspection and visual acceptance sampling, are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.
 
Event Description
The customer states there was a hole in the venous extension.The catheter was repaired and remains in use.
 
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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
edward almeida
15 hampshire street
mansfield, MA 02048
5084524151
MDR Report Key6684564
MDR Text Key78997623
Report Number3009211636-2017-05218
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 06/19/2017
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? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/19/2017
Initial Date FDA Received07/03/2017
Supplement Dates Manufacturer Received07/27/2017
Supplement Dates FDA Received07/27/2017
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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