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

Catalog Number	309579
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that a bd luer-lok¿ syringe was found with foreign matter as the syringe was found with an ¿unknown liquid¿.There was no report of injury or medical intervention reported.
Additional Manufacturer Narrative
A single 3ml syringe with needle attached was received by bd canaan and confirmed to be from batch #6307968.It was visually evaluated.The syringe was observed to have stringing and pooling of silicone between the stopper and the roof of the barrel.The amount of silicone observed was excessive per product specification.Dhr review for batch 6307968: manufacturing dates: 11/22/2016 to 11/25/2016.Batch quantity was (b)(4).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.Silicone weight testing was performed as per requirement with all test results within acceptable range per product specification.Batch 6307968 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Records indicate an issue with silicone tank startup which have affected atomization of silicone in the barrels.The machine automatically rejects a number of barrels after startup.However, if the issue persisted, it may have affected a limited number of barrels post rejection.Based on the sample evaluation: confirmed: bd canaan was able to confirm the customer's indicated failure.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.

• Brand Name: BD LUER-LOK¿ SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7230962
• Report Number: 1213809-2018-00016
• Device Sequence Number: 16616998
• Product Code: FMF
• UDI-Device Identifier: 30382903095798
• UDI-Public: 30382903095798
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2018

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
• Operator of Device: Other
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 309579
• Device Lot Number: 6307968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Initial Date Received by Manufacturer: 01/08/2018
• Supplement Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 01/31/2018
• Supplement Report FDA Received Date: 03/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other