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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.
 
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 Name
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
Type of Device
SET, 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
Type of Report Initial,Followup
Report Date 08/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number367342
Device Catalogue Number367342
Device Lot Number8071903
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/30/2018
Event Location Hospital
Date Report to Manufacturer09/07/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/07/2018
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/11/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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