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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 8813793013
Device Problems Material Frayed (1262); Difficult to Remove (1528); Material Twisted/Bent (2981)
Patient Problem Hematoma (1884)
Event Date 06/30/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, intra-operatively, the patient entered the operating room under general anesthesia to remove and replace a dysfunctional peritoneal catheter with the product. In the first attempt, right internal jugular vein was the first chosen insertion site however as they tried to place the catheter, it caused a bruise and it was corrected by pressing with fingers on the puncture site to stop the bleeding and to decrease the bruise. It was decided to change to left internal jugular vein and the catheter was introduced however only the venous (blue) line had a return flow. A request was made for rx de torax (chest x-ray) to see the position of the tip and detected the tip of the catheter was kinked. It was decided to end the procedure and request support for angiology to remove the product. It was also mentioned that guide wire had became entangled/kinked/bent in the tip (the segment that enters to the intraluminal space of the catheter) during the access placement. There was difficulty encountered while removing the guide w ire. It was stated that the guidewire and catheter were removed from the patient at the same time. The guide wire from the kit was used/utilized. When the guidewire was removed, the device was not intact but no parts of the guide wire left into the patient. Visual inspection was not done. There was blood loss of 50 ml and blood transfusion was not required. The event did not lead to patient hospitalization. Catheter was not repaired, there was no leak and there was no luer adapter issue. Opside was utilized with the device. Clorhexidine was used on the device as cleaning agent and chlorhexidine (chloraprep) was used to clean the patient's skin prior to incision. As the procedure was cancelled and a temporary catheter was no longer placed, replacement was rescheduled for another day to be able to place a new product. The patient was stable.
 
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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
Manufacturer (Section G)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
Manufacturer Contact
lisa hernandez
15 hampshire st.
mansfield, MA 02048
2034925563
MDR Report Key10545564
MDR Text Key207300304
Report Number3009211636-2020-00228
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier10884521004832
UDI-Public10884521004832
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K943349
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8813793013
Device Catalogue Number8813793013
Device Lot Number1906000130
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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