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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
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CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Hemorrhage/Bleeding (1888); Failure of Implant (1924)
Event Type  Injury  
Event Description
Caller (hcp) stated patient had a bleeding event on may 7th and it was suspected the pump was the issue.Caller said patient got better but then had a secondary event where they did an angiogram and it showed the catheter was not in the vein.If you have any questions regarding this letter for manufacturer notification, please do not hesitate to contact us.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
CATHETER
Type of Device
CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
MDR Report Key17317356
MDR Text Key319060312
Report NumberMW5119365
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 07/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Patient Sequence Number1
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