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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. BARD TRIPLE LUMEN PICC CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

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BARD ACCESS SYSTEMS, INC. BARD TRIPLE LUMEN PICC CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Model Number S1385108D
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 12/26/2021
Event Type  malfunction  
Event Description
Tip of picc guidewire broke off during insertion. Fda safety report id# (b)(4).
 
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Brand NameBARD TRIPLE LUMEN PICC
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
MDR Report Key13652041
MDR Text Key286498287
Report NumberMW5107801
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/25/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberS1385108D
Device Lot NumberREFP1050
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided

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