MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD NEEDLE FILTER BLUNT FILL 18X1-1/2; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	305211
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd needle filter blunt fill 18x1-1/2 had foreign matter.The following information was provided by the initial reporter: it was reported that "as part of our quality control, we have been made aware that visible particle adhesions have been detected on some of your needle filters ((b)(4), lot 4212641).These are black residues whose mobility has not yet been conclusively assessed.We would therefore like to ask you to let us know whether you are already aware of this phenomenon and whether any quality reports or assessments have already been made.We are particularly interested in your assessment with regard to patient safety and possible effects during use.We would be very grateful for your feedback and any further information on the affected lot.".
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation.Visible particle adhesions were reported on needle filters.To support the investigation, twenty-four samples in sealed blister packaging and three photographs were submitted for evaluation by the quality team.A visual inspection of the returned samples revealed no defects, imperfections, or foreign matter.The photographs provided depicted a needle plastic shield with a dark-colored speck, a needle hub with a dark colored speck, and the top web of a packaging blister.A review of the device history record for material number 305211, lot 4212641, was completed.The review confirmed that no quality issues were detected during production that could have contributed to the reported condition.There were no related quality notifications, and all processes and final inspections were performed in compliance with specification requirements.Based on the investigation and analysis of the photographs, the reported condition was confirmed; however, it was not observed in the physical samples returned.

• Brand Name: BD NEEDLE FILTER BLUNT FILL 18X1-1/2
• 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: 23541959
• Report Number: 1911916-2025-00738
• Device Sequence Number: 13205486
• Product Code: GAA
• UDI-Device Identifier: 00382903052110
• UDI-Public: (01)00382903052110(17)290930(10)4212641
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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: 4212641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown