MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK; PISTON SYRINGE

Catalog Number	302995
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe 10ml ll s/c 200 contained foreign matter.Verbatim: unopened syringe had mold in packaging.Issue caught prior to pharmacy compounding.No impact to patient.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4).Follow up the customer reported that an unopened syringe contained mold within the packaging.To support the investigation, the quality team received one photograph of a 10 ml luer lok syringe for evaluation.The photograph shows a fully assembled syringe within its packaging.Upon review, a significant amount of loose, unidentified gray foreign material was observed outside the fluid path.The material was located at the bottom of the barrel near the junction between the barrel and the flange and appeared consistent with silicone residue mixed with particulate dirt.This condition is nonconforming to product specifications and is attributable to the assembly process.A device history record review was completed for material number 302995, lot 5267442.The review confirmed that all required visual inspections were performed and found no quality notifications related to the reported condition.The lot was inspected and accepted in accordance with the approved inspection control plan, released for shipment, and is considered compliant with applicable product specification requirements.To date, no other similar events have been reported for this lot.Based on the investigation, including the photograph based evaluation, the customer reported condition is confirmed.

• 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 ; 8473935694
• MDR Report Key: 24650232
• Report Number: 1213809-2026-00142
• Device Sequence Number: 13208074
• Product Code: FMF
• UDI-Device Identifier: 00382903029952
• UDI-Public: (01)00382903029952(17)300831(10)5267442
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 05/07/2026

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: 5267442
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2025
• 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