MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE FILTER 19X1-1/2 TW; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	305200
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It is reported leakage.Event description: filter needle leaked upon pulling up drug.Product#: 217118.Lot#: 2172519.Additional information: any adverse event or serious injury reported to patient or healthcare professional? no.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.A complaint was received regarding leakage from a filter needle during drug aspiration.To support the investigation, three unpackaged samples and one photograph were submitted for evaluation by the quality team.A visual inspection was conducted using magnification at 10x and 30x.No defects or abnormalities were observed.Each sample was subsequently assembled with a syringe to draw and expel a saline solution.No leakage was detected during this functional testing.The photograph provided confirmed the identity of the samples received.A device history record (dhr) review was performed for material number 305200, lot 2172519.The review found no quality issues or deviations during the production of this lot that could have contributed to the reported condition.No related quality notifications were identified, and all manufacturing processes and final inspections were in compliance with specification requirements.Based on the returned sample analysis and supporting documentation, the reported leakage could not be confirmed.

• Brand Name: NEEDLE FILTER 19X1-1/2 TW
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• 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: 22809723
• Report Number: 1911916-2025-00581
• Device Sequence Number: 15691207
• Product Code: GAA
• UDI-Device Identifier: 00382903052004
• UDI-Public: (01)00382903052004(17)270930(10)2172519
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

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: 305200
• Device Lot Number: 2172519
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown