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

Catalog Number	305200
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Material # 305200, lot # 2172519, it was reported by customer that they found reddish brown hard substance on the needle.Verbatim: rcc received a complaint via email.Email(s) attached substance on needle-contaminated" red brown hard substance on the filter needle.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.A reddish-brown, hard substance was reportedly observed on the needle.To support the investigation, one unpackaged sample and one photograph were submitted for evaluation by the quality team.A visual inspection was conducted using 10x and subsequently 30x magnification.No defects, imperfections, or foreign substances¿including the reported reddish-brown material¿were observed on the sample.The submitted photograph depicted a needle assembly without a plastic shield.However, no additional information could be obtained from the image.It is possible that the foreign material was lost during transit or during any preprocessing of the sample prior to its arrival at the manufacturing site.A device history record (dhr) review was completed for material number 305200, lot 2172519.The review found no quality issues during production that could have contributed to the reported condition.No related quality notifications were identified, and all processes and final inspections were performed in accordance with specification requirements.To date, no similar incidents have been reported for this lot.Based on the investigation and analysis of the returned sample, the reported condition 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: 22044245
• Report Number: 1911916-2025-00347
• Device Sequence Number: 15678329
• Product Code: GAA
• UDI-Device Identifier: 30382903052005
• UDI-Public: (01)30382903052005(11)221025(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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2025

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
• 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: 04/28/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 06/06/2025
• 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