MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD LUER-LOK¿ TIP SYRINGE

Catalog Number 302832

Device Problems Detachment Of Device Component (1104); Overfill (2404)

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

Event Date 03/23/2018

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¿ tip syringe ¿while using the syringe for iv fluids, the plunger was pulled back and the rubber stopper came off causing the iv fluid to over fill and cause risk.¿ there was no report of injury or further medical intervention.

Manufacturer Narrative

Investigation summary: a sample was received for evaluation by one of our quality engineers.The sample revealed that the stopper was fully assembled therefore failure mode was not verified.Rolled stoppers can occur intermittently during assembly of the syringe when the plunger rod and stopper subassembly are pressed into the syringe barrel.A misalignment between the barrel and subassembly can cause the rolled stopper.There could have been a stopper not fully assembled but did pass through the cameras allowing it not to be kicked off assembly machine.When one used the syringe and pulled back on the plunger rod this may have caused it to pull away from the bayonet (area holding stopper) allowing it to be unattached.Cameras were implemented 11-19-2015 to detect rolled stoppers during the manufacturing process.Syringes determined to be defective are automatically rejected by the machinery.The camera is challenged every shift to ensure it is functioning as intended.A device history review for lot 7326927-produced on 1/11/18 was completed with zero defects found.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¿ TIP SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7434282
• MDR Text Key: 105903755
• Report Number: 1911916-2018-00168
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903028321
• UDI-Public: 30382903028321
• 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: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 302832
• Device Lot Number: 7326927
• Date Manufacturer Received: 04/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other