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

Catalog Number	305165
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported by customer that black specks inside the needle covers.Additional information: black specs almost look like mold unsure of exact substance.Inside plastic/wrapped needle.
Additional Manufacturer Narrative
(b)(4) follow up.Black specks were reported inside the needle covers.To support the investigation, one photograph was provided to the quality team for evaluation.The image depicts a needle assembly without a packaging blister.Dark colored specks are visible within the plastic shield and appear to be embedded.No additional defects or irregularities were observed.Embedded degraded resin of this nature typically occurs at startup or intermittently during the injection molding process, and the degraded material can break free and become incorporated into molded components.A device history record review was completed for material number 305165, lot 5029287.The review did not identify any quality issues detected during production of this lot that would likely contribute to the reported condition.No related quality notifications were found.All manufacturing processes and final inspections met specification requirements.To date, no other similar events have been reported for this lot.Based on the investigation and the photographic sample evaluation, the condition reported by the customer is confirmed.

• Brand Name: NEEDLE 21X1 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: 24776494
• Report Number: 1911916-2026-00148
• Device Sequence Number: 13258871
• Product Code: FMI
• UDI-Device Identifier: 00382903051656
• UDI-Public: (01)00382903051656(17)300731(10)5029287
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

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: 305165
• Device Lot Number: 5029287
• 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: 03/30/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 04/07/2026
• 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