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	09/09/2025
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 foreign matter in the needle.No patient harm.
Additional Manufacturer Narrative
(b)(4).Follow up it was reported that foreign matter was observed in the needle.Because the physical sample was not returned, a comprehensive evaluation could not be performed.To support the investigation, two photographs were reviewed by the quality team.The images show a needle assembly without its blister packaging, one image depicts the needle with the plastic shield in place and the other without it.A particle is visible adhered near the upper portion of the needle.No additional defects or imperfections were observed.A device history record review was completed for material number 305165, lot 4332109.The review did not identify any quality issues during the manufacture of this lot that could have contributed to the reported condition.No related quality notifications were found.All processes and final inspections were performed in accordance with specification requirements.To date, no other similar events have been reported for this lot.Based on the investigation and the photographic evidence, the customer reported symptom is confirmed.Without the physical sample, a probable root cause could not be determined.

• 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: 24545741
• Report Number: 1911916-2026-00104
• Device Sequence Number: 5688547
• Product Code: FMI
• 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,Followup
• Report Date (Section B): 09/09/2026

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: 4332109
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/08/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 03/21/2026; 09/09/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 03/21/2026; 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown