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	05/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Follow up it was reported that the syringe contained fluid.As a physical sample was not returned, a comprehensive evaluation could not be performed.To support the investigation, one photograph was provided and reviewed by the quality team.The photograph depicted a packaging blister top web, from which no additional relevant details could be determined.A device history record review was conducted for material number 302832, lot 5342566.This review did not identify any quality issues during production that could have contributed to the reported condition, and no related quality notifications were identified.All manufacturing processes and final inspections were completed in accordance with established specification requirements.There have been no other similar events reported for this lot to date.Based on the available information and the photograph provided, the reported issue could not be confirmed.In the absence of a physical sample for evaluation, a probable root cause could not be determined.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.B3.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Event or Problem Description
It is reported, syringe 30ml ll s/c 56 , syringe has some sort of fluid in it.

• 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: 25331666
• Report Number: 1911916-2026-00252
• Device Sequence Number: 21283520
• Product Code: FMF
• UDI-Device Identifier: 00382903028320
• UDI-Public: (01)00382903028320(11)251212(17)301130(10)5342566
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2026

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: 5342566
• 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: 05/15/2026
• Supplement Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown