MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD INTEGRA SYRINGE; SYRINGE ANTISTICK

Lot Number 8002915

Device Problems Material Separation (1562); Volume Accuracy Problem (1675)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Looking at our syringes, it was noted that the ends of the plungers are not level on the perpendicular to the wall of the body of the syringe.This leads to variance in where the rubber end of the plunger meets the lines for measuring volumes depending on how the plunger is rotated in the syringe.For the worst offender i found, the rubber end of the plunger has come away from the plunger itself visibly, with a height variance of greater than 0.1 ml worth of volume at opposite ends of the rubber end of the plunger.As well, at the extremes this problem makes the end of the plunger veer off of center, which i am not certain of the implications but it seems reasonable that this may lead to some medication being left in the syringe or not activating the needle retraction system properly.

• Brand Name: BD INTEGRA SYRINGE
• Type of Device: SYRINGE ANTISTICK
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; franklin lakes NJ 07417
• MDR Report Key: 7681278
• MDR Text Key: 113878624
• Report Number: MW5078343
• Device Sequence Number: 1
• Product Code: MEG
• 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: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Lot Number: 8002915
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/11/2018
• Type of Device Usage: N
• Patient Sequence Number: 1