MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD NEEDLE 21X1-1/2 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305167
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd needle 21x1-1/2 rb had foreign matter.The following information was provided by the initial reporter: material#: 305167, lot#: (b)(4).Rcc received a complaint via email.Sterile needle found with gray/black particulate between needle and cover.Model#: 305167, lot#: 5029915.
Additional Manufacturer Narrative
A sterile needle was reported to contain a particulate between the needle and its cover.Because the physical sample was not returned, a comprehensive evaluation could not be performed.To support the investigation, two photographs were provided for review by the quality team.One image shows the top web of the packaging blister, while the other depicts a needle assembly within the blister, displaying a discoloration that appears to be located between the plastic shield and the blister¿s top web.No additional details could be obtained from the photographs.A review of the device history record for material number: 305167, lot: 5029915, revealed no quality issues during production that could have contributed to the reported condition.There were no related quality notifications, and all processes and final inspections were completed in accordance with specification requirements.To date, no other similar events have been reported for this lot.Based on the investigation and photographic evidence, the customer¿s reported observation is confirmed.However, without the physical sample, it was not possible to determine a probable root cause.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD NEEDLE 21X1-1/2 RB
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23658269
• Report Number: 1911916-2025-00767
• Device Sequence Number: 9896967
• Product Code: FMI
• UDI-Device Identifier: 00382903051670
• UDI-Public: (01)00382903051670(17)300331(10)5029915
• 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
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 11/07/2025

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: Health Professional
• Device Catalogue Number: 305167
• Device Lot Number: 5029915
• 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: 11/04/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown