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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD INTEGRA RETRACTING SYRINGE

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BECTON DICKINSON BD INTEGRA RETRACTING SYRINGE Back to Search Results
Lot Number 3206409
Device Problems Leak/Splash (1354); Defective Component (2292)
Patient Problem No Code Available (3191)
Event Date 02/07/2018
Event Type  Injury  
Event Description
Medical assistant was in the process of administering vaccine (shingrix) to pt when the needle already inside the pt's arm, the vaccine started to leak from the area where the needle gets screwed to the body of the syringe. Our standard syringe is the bd integra syringe and retracting bd precision glide needle. Pt needed to get poked again to receive a complete dose of the vaccine. Pt was understanding. Pt's pcp was informed and she spent extra time explaining to pt about defective syringe and the need to administer a "second" full dose of the vaccine.
 
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Brand NameBD INTEGRA RETRACTING SYRINGE
Type of DeviceBD INTEGRA RETRACTING SYRINGE
Manufacturer (Section D)
BECTON DICKINSON
palo alto CA 94301
MDR Report Key7276172
MDR Text Key100421291
Report NumberMW5075311
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 02/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/30/2018
Device Lot Number3206409
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/15/2018 Patient Sequence Number: 1
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