MAUDE Adverse Event Report: BECTON, DICKSON AND COMPANY BD INTEGRA SYRINGE

Lot Number 7121741

Device Problems Difficult To Position (1467); Device Difficult to Setup or Prepare (1487); Failure to Align (2522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/12/2017

Event Type  malfunction  

Event Description

Nurse had just drawn up a vaccine and when she inspected the bd integra syringe (with attached 25g needle) from the side she noted that the rubber end of the plunger was off center.Vaccine was not used for patient.Upon trying to activate the mechanism to retract the needle the nurse noted that it took significantly more force than normal to activate the mechanism.

• Brand Name: BD INTEGRA SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON, DICKSON AND COMPANY
• MDR Report Key: 6960995
• MDR Text Key: 89852920
• Report Number: MW5072826
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2022
• Device Lot Number: 7121741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1