MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 3ML LL W/NDL SFTYGLD 25X1 RB; SYRINGE, ANTISTICK

Catalog Number	305924
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported, foreign matter.Event description: material # 305924 lot # 4073358 we would like to report this manufacturing defect.The syringe was visibility dirty when removed from packaging.Patient impacted? : no.
Additional Manufacturer Narrative
H11 -a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4) follow up it was reported that the syringe appeared visibly contaminated upon removal from its packaging.As no physical sample was returned, a comprehensive evaluation could not be conducted.However, one photograph was provided and reviewed by our quality team to support the investigation.The image depicts a syringe with dark brown specks consistent with embedded foreign material.This condition is indicative of degraded resin, which can occasionally occur during the injection molding process.Such resin may detach and become incorporated into molded components.A device history record (dhr) review was completed for material number 305924, lot 4073358.The review did not identify any quality issues during the production of this lot that could have contributed to the reported condition.No related quality notifications were found.All manufacturing processes and final inspections were performed in accordance with specification requirements.Additional dhrs were reviewed for each syringe batch used in the production of this final lot.These reviews confirmed that all visual inspections were conducted per established requirements, with no quality notifications related to the reported issue.The lots were inspected and accepted based on our inspection control plan and subsequently approved for shipment.To date, no similar complaints have been reported for this lot.Based on the investigation and analysis of the photographic evidence, the customer¿s reported observation has been confirmed.

• Brand Name: SYRINGE 3ML LL W/NDL SFTYGLD 25X1 RB
• Common Device Name: SYRINGE, ANTISTICK
• 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: 22630008
• Report Number: 1911916-2025-00544
• Device Sequence Number: 9251300
• Product Code: MEG
• UDI-Device Identifier: 00382903059249
• UDI-Public: (01)00382903059249(17)290228(10)4073358
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K992734
• 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): 08/08/2025

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: 305924
• Device Lot Number: 4073358
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown