MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD LUER-LOK; PISTON SYRINGE

Catalog Number	302832
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that brown staining was observed near the plunger.As the physical sample was not returned, a comprehensive evaluation could not be performed.To support the investigation, one photograph was provided for review by the quality team.The image shows a syringe within its packaging blister, displaying discoloration at the syringe barrel flange.Based on the photograph, the discoloration appears to be embedded degraded resin.No additional defects or imperfections were noted.A review of the device history record was conducted for material number 302832, lot 5154021.The review confirmed that no quality issues were detected during the production of this lot that could have contributed to the reported condition.There were no related quality notifications, and all processes and final inspections complied with specification requirements.To date, no other similar events have been reported for this lot.Based on the investigation and the photographic evidence, the condition reported by the customer has been confirmed.Without the actual physical sample analysis, a probable root cause could not be offered.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the bd syringe 30ml ll s/c 56 had foreign matter.The following information was provided by the initial reporter: material: 302832.Batch#: 5154021.Verbatim: rcc received a complaint via phone.Pir attached.This lot in sterile wrap has brown staining by plunger product code# 302832 lot# 5154021.

• Brand Name: BD LUER-LOK
• Common Device Name: PISTON SYRINGE
• 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: 23616601
• Report Number: 1911916-2025-00754
• Device Sequence Number: 9032143
• Product Code: FMF
• UDI-Device Identifier: 00382903028320
• UDI-Public: (01)00382903028320(11)250603(17)300531(10)5154021
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 11/04/2025

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: 302832
• Device Lot Number: 5154021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown