MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK SYRINGE; GENERAL-PURPOSE SYRINGE

Catalog Number	309574
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 five stoppers of five bd¿ luer-lok syringes were defective and improperly suiting into their place, probably causing leakage.
Additional Manufacturer Narrative
Investigation summary: two photos and one 3ml syringe with needle in an opened blister pack from batch #8124923 (p/n 309574) were received.The photos appear to show the same syringe as the physical sample.An insecure stopper condition is observed in the returned sample.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect potential root cause for the insecure stopper defect is associated with the assembly process.No corrective actions are necessary based on the defective rate identified.
Event or Problem Description
It was reported that five stoppers of five bd¿ luer-lok syringes were defective and improperly suiting into their place, probably causing leakage.

• Brand Name: BD LUER-LOK SYRINGE
• Common Device Name: GENERAL-PURPOSE SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8283448
• Report Number: 1213809-2019-00118
• Device Sequence Number: 2389533
• Product Code: FMF
• UDI-Device Identifier: 30382903095743
• UDI-Public: 30382903095743
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2019

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: 04/30/2023
• Device Catalogue Number: 309574
• Device Lot Number: 8124923
• Initial Date Received by Manufacturer: 01/15/2019
• Supplement Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 04/17/2019
• 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