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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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COVIDIEN MFG SOLUTIONS S.A. MAHURKAR CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 8813817009
Device Problems Break (1069); Difficult to Remove (1528)
Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/17/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during the procedure, the guidewire was stuck while inserting the catheter into the patient. The guidewire did not come out of the venous end of ultem adapter and it got stuck inside the catheter. It was also stated that the hcp (healthcare professional) had to use a new catheter and betadine was used as cleaning agent(s) for the device. The catheter was not repaired and there was no leak. There was no luer adapter issue and the insertion site was not treated prior to product placement. There were no patient symptoms or complications associated with the event and tego was not utilized. It was also mentioned that the guidewire provided with the kit was being used and there was no blood leak. Blood transfusion was not need and the procedure was completed. Flushing was done prior to product placement and there was no any medical intervention done to the patient. The guidewire and catheter were removed simultaneously. When the guidewire was removed, the device was not intact but all pieces were accounted for. There was no patient injury.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameMAHURKAR
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
MDR Report Key10004325
MDR Text Key193689455
Report Number3009211636-2020-00090
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K943349
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 01/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/08/2022
Device Model Number8813817009
Device Catalogue Number8813817009
Device Lot Number1703900091
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2020
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2020
Is This a Reprocessed and Reused Single-Use Device? No

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