MAUDE Adverse Event Report: BECTON DICKINSON HYPODERMIC NEEDLE; SYRINGE WITH NEEDLE

Catalog Number	302894
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.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 before use a bd¿ needle was found with foreign matter in the hub of the cannula.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: dhr review: a review of the dhr shows that all product met specifications, and there were no issues related to fm or burrs on the hubs documented.Three photos were received in the columbus plant for evaluation.The specification for horizontal ear flash is ¿not to exceed.005¿, but not greater than.010¿, it must be thin and flexible so as not to interfere with engagement to a luer lok® barrel¿.Based on the photos the flash in question does not exceed the specification limits.The burr on the hub appears to be firmly attached.It didn¿t detach from the hub during repeated handling during molding and assembly so the risk of detachment during use would be minimal.Eleven samples were also returned.No evidence of foreign matter or flash was observed.Conclusion: the hubs are air-veyed from the press to a container, from the hub hopper to the assembly line, and from the assembly line to the auto-bagger.Repeated handling may have caused the burr.The embedded foreign matter is variation in the color concentrate we use.It is a normal occurrence.An absolute root cause for this incident cannot be determined.

• Brand Name: HYPODERMIC NEEDLE
• Common Device Name: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7113175
• Report Number: 2243072-2017-00386
• Device Sequence Number: 1495293
• Product Code: FMI
• UDI-Device Identifier: 50382903028943
• UDI-Public: 50382903028943
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2018

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 Catalogue Number: 302894
• Device Lot Number: 6274726
• Initial Date Received by Manufacturer: 11/20/2017
• Supplement Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 02/02/2018
• 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