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

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forward, pushing out the remaining medicine out around the base of the needle.In one instance, when the plunger was withdrawn following the collapse of the plunger, the needle was completely drawn into the syringe itself.The needle has not been pushed completely out of the syringe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.

• Brand Name: BD INTEGRA SYRINGE 23GX1
• Type of Device: BD INTEGRA SYRINGE 23GX1
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY
• MDR Report Key: 11342970
• MDR Text Key: 232813204
• Report Number: MW5099447
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 02/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 305271
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 95