MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY NEEDLE 19GA 1IN TW; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305186
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: one (1) sample was provided by the customer for investigation.The sample was analyzed visually and identified a piece of white foreign matter (fm) approximately 2mm (0.08 inches) in length.The needle was removed from the hub and it was observed that the fm is loose and not attached to the needle.This fm could have come from either an operator or from the manufacturing equipment or environment however a definitive root cause could not be determined.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Investigation conclusion: a complaint history check was performed and this is the 1st related complaint reported with the defect/condition of foreign matter for lot #8228942 item #305186.A device history record (dhr) review was performed on the batch associated with this investigation.The dhr review did not reveal any defects or issues reported and no quality notifications were issued.Root cause description: this fm could have come from either an operator or from the manufacturing equipment or environment.
Event or Problem Description
It was reported that foreign matter was found with a needle 19ga 1in tw.The following information was provided by the initial reporter, "material no: 305186, batch no: 8228942.It was reported that the there is white debris on the tip of the needle.Event description per snow verbatim states, "there is a white debris on the tip of the needle".

• Brand Name: NEEDLE 19GA 1IN TW
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 8584359
• Report Number: 1911916-2019-00446
• Device Sequence Number: 11214967
• Product Code: FMI
• UDI-Device Identifier: 30382903051862
• UDI-Public: 30382903051862
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• 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
• Report Date (Section B): 04/18/2019

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: 10/31/2023
• Device Catalogue Number: 305186
• Device Lot Number: 8228942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 05/06/2019
• 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