MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD® NEEDLE 1 IN. SINGLE USE, STERILE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305165
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.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 the bd® needle 1 in.Single use, sterile had foreign matter.The following was received by the initial reporter: customer reported a black spec was noticed in the hub of the 21 g needle (305165).
Additional Manufacturer Narrative
It was reported a black spec was noticed in the hub of the needle.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows three different needle assemblies with the needles inserted into a vial.The needle assembly with a green hub has a dark color dot on the needle hub.No other defects or imperfections were observed.A device history record review was completed for provided material number 305165, lot 2228049.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed, but without the physical sample analysis a probable root cause could not be offered.H3 other text : see h10.
Event or Problem Description
It was reported that the bd® needle 1 in.Single use, sterile had foreign matter.The following was received by the initial reporter: customer reported a black spec was noticed in the hub of the 21 g needle (305165).

• Brand Name: BD® NEEDLE 1 IN. SINGLE USE, STERILE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17799640
• Report Number: 1911916-2023-00682
• Device Sequence Number: 7147105
• Product Code: FMI
• UDI-Device Identifier: 30382903051657
• UDI-Public: (01)30382903051657
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2023

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 Catalogue Number: 305165
• Device Lot Number: 2228049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown