MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ DISPOSABLE SYRINGE

Catalog Number 309628

Device Problems Mechanical Problem (1384); Physical Resistance (2578); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/17/2018

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 during use of the bd luer-lok¿ disposable syringe the plunger on the device is difficult to move.The customer stated ¿when the drug is pulled up, it is noted that the plunger is slightly difficult to pull/move.Feels either that the black part of the plunger creates strong friction against the inside of the syringe, or that the syringe narrows when it reaches a smaller amount¿ there was no report of injury or further medical intervention.

Manufacturer Narrative

Additional information: an additional device was returned with a different lot # than the one reported.It was medical device lot #: 7177887.Medical device expiration date: 06/30/2022.Manufacture date: 06/26/2017.Investigation results: total of three 1ml luer-lok syringes were received.1 was in an opened package, confirmed to be from batch # 7300852 (p/n 309628), while 2 were in sealed packages, confirmed to be from batch #7177887 (p/n 309628).Samples were evaluated.Two sealed 1ml syringes were tested in the lab for ¿breakout and sustaining force." both syringes passed both tests per product specification.The opened package syringe was not tested due to having been manipulated which could affect the results of the test.However, its plunger was manually exercised and it moved freely without interruptions, indicating sufficient lubrication of the stopper and the barrel.Product defect was not confirmed based on sample evaluation.Dhr review for batch 7300852 (p/n 309628): manufacturing dates: 11/22/2017 to 11/26/2017.Batch quantity was 302,400.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch7300852 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Dhr review for batch 7177887 (p/n309628): manufacturing dates: 07/16/2017 to 07/17/2017.Batch quantity was 302,400.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 7177887 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.The review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Root cause and capa not required as no defects were confirmed.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.

• Brand Name: BD LUER-LOK¿ DISPOSABLE SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7405196
• MDR Text Key: 104832776
• Report Number: 1213809-2018-00229
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096283
• UDI-Public: 30382903096283
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 309628
• Device Lot Number: 7177887
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 04/06/2018
• Supplement Dates Manufacturer Received: 04/03/2018
• Supplement Dates FDA Received: 05/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other