MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL Luer-Lok; Syringe, Piston

Catalog Number	309653
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, syringe 50 ml ll, contamination.The following was provided by the initial reporter: i have been notified of 2 more of the 50ml bd syringes that are contaminated.
Additional Manufacturer Narrative
B3.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4) follow up it was reported there were two more of the 50ml syringes that are contaminated.Due to the absence of a physical sample, photographic evidence, or lot number, our quality engineering team was unable to conduct a comprehensive investigation.Current quality controls are in place to identify such defects during the production process.Based on the limited investigation, the cause of the reported incident remains undetermined.If you encounter any further issues with our product, we would appreciate the opportunity to perform a thorough analysis.Examination of the involved product may provide insights into the cause of the reported failure.Complaints regarding this device and the reported condition will continue to be monitored and analyzed.Our quality team regularly reviews collected data to identify emerging trends.

• 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 ; +1(847)393-5694
• MDR Report Key: 50915174
• Report Number: 1911916-2026-00519
• Device Sequence Number: 17580804
• Product Code: FMF
• UDI-Device Identifier: 00382903096534
• UDI-Public: (01)00382903096534
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• 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): 10/01/2026

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: 309653
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2026
• Supplement Date Received by Manufacturer: 10/01/2026
• Initial Report FDA Received Date: 09/28/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown