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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET SET, ADMINISTRATION, INTRAVASCULAR

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BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 367342
Device Problem Retraction Problem (1536)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/23/2018
Event Type  malfunction  
Event Description
Bd vacutainer push button blood collection set 23g 3/4", needle is self retracting while inserted in vein.
 
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Brand NameBD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BECTON, DICKINSON & CO., (BD)
1575 airport rd
sumter SC 29153
MDR Report Key7854717
MDR Text Key119498049
Report Number7854717
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 08/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model Number367342
Device Catalogue Number367342
Device Lot Number8071903
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/30/2018
Event Location Hospital
Date Report to Manufacturer09/07/2018
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

Patient Treatment Data
Date Received: 09/07/2018 Patient Sequence Number: 1
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