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

Catalog Number	305211
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that syringe was leaking, needle dis-guarded.Can you please provide an exact date of event in format (b)(6) 2026 what was the medication/fluid in use at the time of the event? izervay when was this defect observed? during or before use? the leak occurred after the medication was withdrawn from the vial.Before administration to the patient.Was there a delay of, or change in, the course of treatment due to the event? yes, another kit had to be used by the hcp.
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
No additional information.
Additional Manufacturer Narrative
Investigation summary: based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed.We will continue monitoring the complaint trend for the product and symptom.Without the physical sample analysis, a probable root cause could not be offered.

• Brand Name: 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: 25160310
• Report Number: 1911916-2026-00219
• Device Sequence Number: 10694524
• Product Code: GAA
• UDI-Device Identifier: 00382903052110
• UDI-Public: (01)00382903052110(17)300228(10)5002078
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K941562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

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: 5002078
• 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: 04/24/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown