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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD INTEGRA SYRINGE 23GX1

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BECTON, DICKINSON AND COMPANY BD INTEGRA SYRINGE 23GX1 Back to Search Results
Catalog Number 305271
Device Problems Collapse (1099); Loose or Intermittent Connection (1371)
Patient Problem Insufficient Information (4580)
Event Date 02/13/2021
Event Type  malfunction  
Event Description
Item: bd integra syringe, 23gx1 (0. 6mm x 25mm), ref 305271. Received syringes for injections of testosterone cypriate (0. 5 ml) had a (b)(4) failure rate over 4 random syringes from a brand new box. The needle comes loose under injection pressure. Plunger pops the needle loose, plunger thrusts forward, pushing out the remaining medicine out around the base of the needle. In one instance, when the plunger was withdrawn following the collapse of the plunger, the needle was completely drawn into the syringe itself. The needle has not been pushed completely out of the syringe into the patient, but no assurance it won't happen.
 
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Brand NameBD INTEGRA SYRINGE 23GX1
Type of DeviceBD INTEGRA SYRINGE 23GX1
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
MDR Report Key11342970
MDR Text Key232813204
Report NumberMW5099447
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 02/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number305271
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
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?
Type of Device Usage

Patient Treatment Data
Date Received: 02/17/2021 Patient Sequence Number: 1
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