MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE; PISTON SYRINGE

Catalog Number 309646

Device Problem Difficult to Remove (1528)

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

Event Date 10/03/2018

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 that a bd luer-lok¿ syringe sterile, single use had a plunger that was hard to pull back.There was no report of exposure, serious injury, or medical intervention.

Manufacturer Narrative

Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.Dhr review for batch 8035612 ((b)(4).Manufacturing dates: 02/12/2018 to 02/14/2018.Batch quantity was 480,000.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 8035612 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.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 a bd luer-lok¿ syringe sterile, single use had a plunger that was hard to pull back.There was no report of exposure, serious injury, or medical intervention.

• Brand Name: BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7996885
• MDR Text Key: 124829648
• Report Number: 1213809-2018-00696
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096467
• UDI-Public: 30382903096467
• 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: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 309646
• Device Lot Number: 8035612
• Date Manufacturer Received: 10/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other