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

Catalog Number 309657

Device Problem Moisture Damage (1405)

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

Event Date 12/14/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 before use, a bd luer-lok¿ disposable syringe with bd luer-lok¿ tip with a moisture / gooey substance.There was no report of injury or medical intervention reported.

Manufacturer Narrative

Investigation results: sample evaluation: one open 3ml packaged syringe was received by bd canaan and confirmed to be from batch #7155789 (p/n 309657).The sample was visually evaluated.The ¿moisture¿ observed on the black stopper is silicone used in the manufacturing process.The small amount observed was a normal and expected amount for this product per product specification.Dhr review for batch 7155789 (p/n 309657): manufacturing dates: 6/25/2017 to 06/27/2017.Batch quantity was 768,000.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 7155789 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Silicone is an inert, non-toxic medical substance used as a lubricant for disposable hypodermic products.It is an integral part of the syringe, enabling it to perform as required in various clinical applications and does not present a safety or efficacy issue nor does it impact product function.The silicone application process is designed to provide an even distribution of silicone on the interior of the syringe barrel.Silicone has been in use in this application for over 20 years.No reports are known of adverse clinical effects associated with these products and unintentional delivery of silicone fluid lubricant.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.Bd canaan was not able to duplicate or confirm the customer's indicated failure.Capa is not required as no defects were confirmed.

• 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: 7170173
• MDR Text Key: 96897613
• Report Number: 1213809-2017-00418
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096573
• UDI-Public: 30382903096573
• Combination Product (y/n): N
• PMA/PMN Number: K110771
• 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: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 309657
• Device Lot Number: 7155789
• Date Manufacturer Received: 12/14/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other