MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD NEEDLE FILTER 19X1-1/2 TW; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	305200
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd needle filter 19x1-1/2 tw had a syringe needle connectivity issue.The following information was provided by the initial reporter: material # 305200, possible batch # 2199683, 2172519.Verbatim: rcc received a complaint via email.Needle came off from syringe caused leak of medication.(in detail."the medication was already out of the vial and into the syringe but when it was being suppressed to gather the medication together in the syringe the needle came off at that time with medication leaving the syringe as well.During this time of putting the needle back on the tip of the syringe was touched making it non-sterile".) product#: 305200, 309628."the doctor felt this became unsterile and unsafe to administer to patient.".
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation.It was reported that the needle detached from the syringe.To support the investigation, two photographs, one empty izervay shelf box, a 1 ml syringe, and a 19g 1½-inch needle assembly without its packaging blister or plastic shield were received for evaluation by the quality team.A visual inspection revealed no defects or imperfections.The needle was then assembled onto a syringe filled with saline solution, and the solution was expelled with normal flow through the needle tip.No leakage was observed, and the needle remained securely attached to the syringe throughout testing.The photographs provided depicted a packaging shelf box, a syringe with a yellow hub needle attached, and a needle inserted into a vial.No additional information could be obtained from the images.A device history record review was conducted for material number 305200, covering possible lots 2199683 and 2172519.The review did not identify any quality issues during production that could have contributed to the reported condition.No related quality notifications were found, and all processes and final inspections were performed in compliance with specification requirements.Based on the investigation and analysis of the returned sample, the reported symptom could not be confirmed.

• Brand Name: BD NEEDLE FILTER 19X1-1/2 TW
• 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: 23798720
• Report Number: 1911916-2025-00797
• Device Sequence Number: 13078349
• Product Code: GAA
• UDI-Device Identifier: 00382903052004
• UDI-Public: (01)00382903052004(17)270930(10)2199683
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 12/13/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown