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

Catalog Number	309634
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/10/2018
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 plungers of bd¿ luer-lok were deformed before use.
Event or Problem Description
It was reported that plungers of bd¿ luer-lok were deformed before use.
Additional Manufacturer Narrative
Investigation summary: one loose 5ml ll syringe and four open packages from batch # 8294973 (p/n 309634) were received.A visual examination of the syringe determined the defect was a jammed stopper wedged in between the plunger rod and the barrel.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 jammed stopper defect is associated with the assembly process.No corrective actions are necessary based on the defective rate identified.

• Brand Name: BD¿ LUER-LOK
• Common Device Name: GENERAL-PURPOSE SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8204012
• Report Number: 1213809-2018-00936
• Device Sequence Number: 19350150
• Product Code: FMF
• UDI-Device Identifier: 30382903096344
• UDI-Public: 30382903096344
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2019

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: 09/30/2023
• Device Catalogue Number: 309634
• Device Lot Number: 8294973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 03/18/2019
• 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