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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD NEXIVA - 22 GA 1.00 IN CLOSED CATHETER IV SINGLE PORT CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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BD BD NEXIVA - 22 GA 1.00 IN CLOSED CATHETER IV SINGLE PORT CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Lot Number 1362419
Device Problem Fluid/Blood Leak (1250)
Patient Problem Insufficient Information (4580)
Event Date 03/21/2022
Event Type  malfunction  
Event Description
While performing initial nss flush of newly inserted iv catheter discovered fluid leaked out of a crack inside of catheter at upper portion near the blue wings. Fda safety report id # (b)(4).
 
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Brand NameBD NEXIVA - 22 GA 1.00 IN CLOSED CATHETER IV SINGLE PORT
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BD
MDR Report Key13863338
MDR Text Key287821094
Report NumberMW5108462
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 Risk Manager
Type of Report Initial
Report Date 03/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number1362419
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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