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

Catalog Number	302832
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that particulate was observed in the final product.As a physical sample was not returned, a comprehensive sample evaluation could not be conducted.To support the investigation, one report containing four photographs and two charts was reviewed by the quality team.The photographs depict a particle recovered from a 50 ml falcon tube.One chart, associated with particle 1, indicates a match to cellulosic material, while the second chart, associated with particle 2, indicates a match to earwax; however, no percentage match values were provided.The probable materials identified in the charts are not associated with the syringe manufacturing process.The process is fully automated and does not involve direct handling of the units by associates.A device history record review was performed for material number (b)(4), lot number 3163953.This review did not identify any quality issues during production that could have contributed to the reported condition, and no related quality notifications were found.All manufacturing processes and final inspections were completed in accordance with established specification requirements.The manufacturing process is controlled, not classified.Based on the available investigation data, the customer-reported condition could not be confirmed.In the absence of a returned physical sample for evaluation, a probable root cause could not be determined.
Event or Problem Description
It is reported, syringe 30 ml, extrinsic particulate (cerumen - earwax) observed in final product.No patient harm.

• Brand Name: LUER-LOK
• Common Device Name: SYRINGE, PISTON
• 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: 25306527
• Report Number: 1911916-2026-00243
• Device Sequence Number: 18520924
• Product Code: FMF
• UDI-Device Identifier: 00382903028320
• UDI-Public: (01)00382903028320(11)230706(17)280630(10)3163953
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2026

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: 3163953
• 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: 05/11/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown