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

Catalog Number	305200
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
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
It was reported by customer that "unknown black spots on syringe and needle" verbatim: material # 305200 & batch # 2199683.Please initiate a complaint investigation and have it completed within 45-60 days referencing astellas record # cn-011940 for ¿unknown black spots on syringe and needle¿.Per the nurse at the eye clinic, the black spots appear to be inside the needle cap, and inside the syringe.See attached report for details.
Additional Manufacturer Narrative
Pr (b)(4) follow up for device evaluation an issue was reported involving unidentified black spots observed on a needle.To support the investigation, one sample with no packaging blister and one photograph was provided and reviewed by our quality team.A visual inspection was performed, and the plastic shield has dark colored embedded specks.The image depicts a vial adjacent to a needle with a plastic shield assembled onto a syringe.No additional information could be derived from the photograph.The presence of embedded degraded resin is typically associated with the startup phase or intermittent occurrences during the injection molding process.During these times, degraded resin may dislodge and become incorporated into molded components.A review of the device history record (dhr) was completed for material number 305200, lot 2199683.The review found no quality issues during the manufacturing process that could be linked to the reported condition.There were no associated quality notifications, and all processes and final inspections were performed in accordance with specification requirements.The sample will be shown to associates for awareness.To date, no similar incidents have been reported for this lot.Based on the investigation with the returned sample analysis, the customer-reported issue is confirmed.

• Brand Name: NEEDLE FILTER 19X1-1/2
• 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: 22289237
• Report Number: 1911916-2025-00426
• Device Sequence Number: 8893475
• Product Code: GAA
• UDI-Device Identifier: 30382903052005
• UDI-Public: (01)30382903052005(11)221025(17)270930(10)2199683
• 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): 07/08/2025

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: 2199683
• 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: 06/03/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 07/08/2025
• 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