MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD 60ML SYRINGE LUER-LOK TIP; PISTON SYRINGE

Catalog Number 309653

Device Problems Leak/Splash (1354); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 02/12/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a bd 60ml syringe luer-lok¿ tip did not seal properly between the plunger and barrel and leaked.The report is as follows, "the pharmacy is reporting that a 60ml syringe they are using to draw up medications are not sealing properly between the plunger and barrel of the syringe.This is causing the medication to leak past the plunger.".

Manufacturer Narrative

One sample was received.Visual inspection was performed finding no defects.It was tested for leakage and it passed with no leakage noted, therefore failure mode was not verified.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.This is the 1st complaint for the lot# 8270800 for the same defects or symptoms.There was no documentation of issues for the complaint of batch # 8270800 during this production run.

Event Description

It was reported that a bd 60ml syringe luer-lok¿ tip did not seal properly between the plunger and barrel and leaked.The report is as follows, "the pharmacy is reporting that a 60ml syringe they are using to draw up medications are not sealing properly between the plunger and barrel of the syringe.This is causing the medication to leak past the plunger.".

• Brand Name: BD 60ML SYRINGE LUER-LOK TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 8391986
• MDR Text Key: 138082992
• Report Number: 1911916-2019-00239
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096535
• UDI-Public: 30382903096535
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 309653
• Device Lot Number: 8270800
• Date Manufacturer Received: 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other