MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD BLUNT FILTER NRFIT; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	305211
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	09/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint was received regarding black spots on the needle.To support the investigation, seven photographs were provided for evaluation by the quality team.The images depict a needle assembly without packaging.The plastic shield shows dark specks of embedded, degraded resin no other defects or imperfections were observed.Embedded degraded resin typically arises at startup or intermittently during the injection molding process, when degraded material can detach and be carried into subsequent shots, becoming incorporated into molded components.A device history record review was completed for material number 305211, lot 4116650.The review did not identify any quality issues during production that could have contributed to the reported condition.There were no related quality notifications, and all processes and final inspections complied with specification requirements.To date, no similar events have been reported for this lot.Based on the investigation and analysis of the photographic samples, the customer reported condition is confirmed.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that bd needle filter blunt fill 18x1-1/2 contained foreign matter.Verbatim: the physician noted black spots on the needle that was provided with the eylea kit.

• Brand Name: BD BLUNT FILTER NRFIT
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• 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: 23954433
• Report Number: 1911916-2025-00825
• Device Sequence Number: 5740040
• Product Code: GAA
• UDI-Device Identifier: 00382903052110
• UDI-Public: (01)00382903052110(17)290630(10)4116650
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2025

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: 305211
• Device Lot Number: 4116650
• 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: 12/12/2025
• Initial Report FDA Received Date: 01/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown