MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 20X1-1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305176
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: it was reported the end of the hub broke off while drawing up medication.To aid in the investigation, two samples were received for evaluation by our quality team.One sample has the needle hub damaged and a piece of the needle hub is in a syringe luer lock.The needle hub is damaged at the middle of the hub and this breakage is irregular.The second sample was inspected finding no defects or imperfections.This defect could occur when assembling the plastic shield if the fixture holding the needle assembly was not centered inducing stress to the needle hub which later became broken.A device history record review was completed for provided material number 305176, lot number 0322047.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Verification of the fixtures, shielder and centering was performed.No conditions that could induce this symptom were observed and the flow of products was good.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the needle 20x1-1/2 rb experienced a damaged needle hub.The following information was provided by the initial reporter: i have a product failure to report that occurred (b)(6) 2021.No patient involvement-plastic end of hub broke off while drawing up medication.

• Brand Name: NEEDLE 20X1-1/2 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 12439710
• Report Number: 1911916-2021-00952
• Device Sequence Number: 3891178
• Product Code: FMI
• UDI-Device Identifier: 30382903051763
• UDI-Public: 30382903051763
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/31/2025
• Device Model Number: 305176
• Device Catalogue Number: 305176
• Device Lot Number: 0322047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1