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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 Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/09/2021
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 dialysis session, leakage was observed and on disconnection a crack was noted on the red (arterial) luer adapter. Dialysis was stopped and a new catheter was inserted. Treatment was completed successfully. There was a blood loss of approximately 5 ml, but no blood transfusion required. Flushing was done successfully prior to use. The catheter was not repaired and no tego utilized. Chlorhexidine was the cleaning agent typically utilized to clean the adapters. Betadine was the cleaning agent used on the insertion site prior to product placement. The cleaning agents were allowed to dry thoroughly prior to applying ointment to the area. There was no instrument but only hand was used to loosen or tighten the adapters. There were no other products being utilized with the device. There was nothing unusual observed on the device prior to use. There were no patient symptoms or complications associated with the event. There was no patient injury.
 
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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
CS 20101
Manufacturer (Section G)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
CS 20101
Manufacturer Contact
avi kluger
5920 longbow drive
boulder, CO 80301
3035306582
MDR Report Key12239241
MDR Text Key264043998
Report Number3009211636-2021-00180
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K943349
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 12/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8813817009
Device Catalogue Number8813817009
Device Lot Number1933700114
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/09/2020
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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