MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD Luer-Lok; Piston Syringe

Catalog Number	302995
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe 10ml ll s/c contained foreign matter.Verbatim: complaint via email.Email(s) attached.Caller asked to clarify the location of the moisture.Is the moisture noted in the barrel or package.Caller informed that bd syringe contains a medical grade silicone lubricant.If the moisture is inside the syringe, it could be the silicone lubricant.If it's in the package, it could be a humidity/temperature issue.Per caller the moisture in the barrel of the syringe.Advised following instructions given by product complaints.Caller requested document stating the materials of the syringe.Emailed the syringe tds per request.Caller advised to have customer reach out to us directly at xxxx with questions.
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: BD Luer-Lok
• Common Device Name: Piston Syringe
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; +1(847)393-5694
• MDR Report Key: 50736914
• Report Number: 1213809-2026-00469
• Device Sequence Number: 10662579
• Product Code: FMF
• UDI-Device Identifier: 00382903029952
• UDI-Public: (01)00382903029952
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2026

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: Other
• Device Catalogue Number: 302995
• 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: 08/25/2026
• Supplement Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 09/11/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown