MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE LUER-LOK¿ TIP; PISTON SYRINGE

Catalog Number 301029

Device Problems Mechanical Problem (1384); Difficult to Open or Close (2921)

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

Event Date 09/28/2018

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7332854, medical device expiration date: 2022-11-30, device manufacture date: 2017-11-28.Medical device lot #: 7278957, medical device expiration date: 2022-09-30, device manufacture date: 2017-10-05.(b)(6).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 the bd syringes with the luer-lok¿ tip were "hard to open" due to difficult plunger movement.There was no report of exposure, injury, or medical intervention.

Manufacturer Narrative

A single loose 10ml syringe was received inside an open sample pouch taped together on one end.The sample was evaluated.The stopper was in the bottom out position.No visual defects were observed.A small amount of silicone was observed on the stopper, which is normal for this product per specification.The plunger with the stopper was pulled back.After the initial normal feel of the breakout force the plunger and stopper movement was smooth without any issues.The plunger was taken out and stopper evaluated.The stopper was confirmed to be siliconized.No manufacturing defects have been found in the sample received.A device history record review showed no rejected inspections or quality issues during the production of the provided lot numbers that could have contributed to the reported defect.The reported defect was not identified in the sample received.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.

Event Description

It was reported that the bd syringes with the luer-lok tip were "hard to open" due to difficult plunger movement.There was no report of exposure, injury, or medical intervention.

• Brand Name: BD SYRINGE LUER-LOK¿ TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7986183
• MDR Text Key: 124667788
• Report Number: 1213809-2018-00715
• Device Sequence Number: 1
• Product Code: FMF
• 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: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301029
• Device Lot Number: SEE SECTION H.10.
• Date Manufacturer Received: 09/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other