MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD PLASTIC NON-STERILE LUER-LOK¿ TIP SYRINGE

Catalog Number 301027

Device Problems Break (1069); Failure to Align (2522); Device Operates Differently Than Expected (2913); Appropriate Term/Code Not Available (3191)

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

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(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 plastic non-sterile luer-lok¿ tip syringe had multiple issues including; damage, inclusions, mis-aligned gasket, and printing problems.Found before use.No reports of serious injury or medical interventions noted.

Manufacturer Narrative

Investigation summary: a bag contained four loose 5ml syringes was received, reported to be from batch # 7239853.The samples were visually evaluated.One syringe was found to have minor contact ink smear and minor print imperfection to the graduated lines around 2ml, which is an acceptable condition per specification.One syringe was found to have all numeical markings missing.One syrine had embedded foreign matter larger than level 3 in size and missing print - all numerical markings missing.One syringe had missing print of grad lines between 1ml and 3ml due to scratch in the barrel.All stoppers were correctly positioned on the plungers.The missing print and embedded foreign matter observed is a rejectable condition per product specification.Product defect could be confirmed based on samples received.Dhr review for batch 7239853 : manufacturing dates:09/04/2017 to 09/05/2017.Batch quantity was (b)(4).Printing and assembly records were reviewed as part of this dhr review.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 7239853 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Investigation conclusion: the embedded fm is most likely degraded plastic.This occurs when the resin is exposed to prolonged high temperatures inside the molding machine, such as during start up.For missing print due to damage: likely isolated incident that occurred during assembly process.For missing print at marker: undetermined.

• Brand Name: BD PLASTIC NON-STERILE LUER-LOK¿ TIP SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7516078
• MDR Text Key: 108496059
• Report Number: 1213809-2018-00298
• 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: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

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: 08/31/2022
• Device Catalogue Number: 301027
• Device Lot Number: 7239853
• Initial Date Manufacturer Received: 05/01/2018
• Initial Date FDA Received: 05/15/2018
• Supplement Dates Manufacturer Received: 05/01/2018
• Supplement Dates FDA Received: 06/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other