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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD SAF-T-INTIMA CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BECTON, DICKINSON AND COMPANY BD SAF-T-INTIMA CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Lot Number 1015155
Device Problem Fluid Leak (1250)
Patient Problem Insufficient Information (4580)
Event Date 06/15/2021
Event Type  malfunction  
Event Description
We recently had a safety report filed by our lab services department related to the butterfly needles. Essentially, instead of the blood flowing into the tubing, it went into the plastic hub surrounding the tubing and leaked over the patients¿ arms. This occurred twice. Manufacturer response for butterfly needle, (brand not provided) (per site reporter): none at this time.
 
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Brand NameBD SAF-T-INTIMA
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
1 becton drive
franklin lakes NJ 07417
MDR Report Key12597839
MDR Text Key275401992
Report Number12597839
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number1015155
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/30/2021
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer10/08/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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