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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR ELITE; CATHETER, HEMODIALYSIS, NON-IMPLANTED
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COVIDIEN MFG SOLUTIONS S.A. MAHURKAR ELITE; CATHETER, HEMODIALYSIS, NON-IMPLANTED Back to Search Results
Model Number 8888211416
Device Problem Break (1069)
Patient Problems Foreign Body In Patient (2687); No Information (3190)
Event Date 12/12/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, the guide wire that was used for dialysis catheter placement kit was broken into pieces with the needle.It was also stated that both pieces were retrieved and appear intact.There was no reported patient outcome.
 
Event Description
According to the reporter, the guide wire that was used for dialysis catheter placement kit was broken into pieces with the needle.It was also stated that both pieces were retrieved and appear intact.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
MAHURKAR ELITE
Type of Device
CATHETER, HEMODIALYSIS, NON-IMPLANTED
Manufacturer (Section D)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
MDR Report Key9590878
MDR Text Key194159420
Report Number3009211636-2020-00017
Device Sequence Number1
Product Code MPB
UDI-Device Identifier10884521126015
UDI-Public10884521126015
Combination Product (y/n)N
PMA/PMN Number
K120674
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 02/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8888211416
Device Catalogue Number8888211416
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/03/2020
Initial Date FDA Received01/15/2020
Supplement Dates Manufacturer Received01/25/2020
Supplement Dates FDA Received02/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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