MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE FILTER BLUNT FILL; Needle, Aspiration And Injection, Disposable

Catalog Number	305211
Medical Device Problem Codes	Leak/Splash (1354); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, needle filter blunt fill, filter needle not securely attached to luer lock, causing leak.The following was provided by the initial provider: on (b)(6)2026, xxxxx received a complaint from a reporter regarding a xxxxxx, lot 2189856.The reporter stated that the included filter needle did not securely attach to the luer lock connection, resulting in difficulty drawing up the medication properly.The physician further reported that when attempting to expel excess air bubbles through the filter needle, medication leaked from the needle hub at the luer lock connection, resulting in product waste.The vial was prepared for administration using a syringe and needle; however, the product was not administered to the patient.No adverse event was reported, and there was no risk to patient safety.No further issues have been reported.Event date: (b)(6)2026, root cause (undetermined): root cause (undetermined).Potential root cause(s): incomplete engagement between the filter needle hub and the syringe luer lock connection, resulting in an inadequate seal and leakage during medication draw-up or air purging.User technique during assembly, including failure to fully secure the filter needle to the syringe prior to use.User technique during air/bubble removal, resulting in increased pressure at the connection and subsequent leakage.End-user assembly and handling practices contributing to inadequate connection integrity during product preparation.An undetected component defect of the filter needle hub or syringe connection interface that was not observable during visual inspection.Potential ae: no adverse event.
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.

• Brand Name: NEEDLE FILTER BLUNT FILL
• 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 ; +1(847)393-5694
• MDR Report Key: 50868478
• Report Number: 1911916-2026-00511
• Device Sequence Number: 13430514
• Product Code: GAA
• UDI-Device Identifier: 00382903052110
• UDI-Public: (01)00382903052110(17)300531(10)5092856
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K941562
• 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
• Report Date (Section B): 09/22/2026

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: 305211
• Device Lot Number: 5092856
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown