MAUDE Adverse Event Report: EMBECTA MEDICAL I LLC BD LUER-LOK; PISTON SYRINGE

Catalog Number	309702
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd syringe 3ml ll tip bulk convenience pak contained foreign matter.Complaint via email.Dmr # (b)(4) po #: (b)(4) defect material description: syringe tray, 3ml bd 25pk (ref.309702) lot number: 5331880 item code: 309702 defective quantity:1.Defect description: particulate found in 3ml bd syringe.Ftir was destructive testing.The ftir analysis came back as cardboard.Sample not available to be returned.Observed date: (b)(6) 2026 observed during which process stage: ilp.Ir/ dmi number if launched: (b)(4) sample availability for supplier to investigate: no is defective evidence (i.E.Pictures, test results etc.) available? yes is patient impacted? no if defect has been reported to third party? no if the defect report from quva customer? no is there a trend observed? no.

• Brand Name: BD LUER-LOK
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): EMBECTA MEDICAL I LLC; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): EMBECTA MEDICAL I LLC; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24915765
• Report Number: 2243072-2026-00288
• Device Sequence Number: 13060551
• Product Code: FMF
• UDI-Device Identifier: 30382903097020
• UDI-Public: (01)30382903097020
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

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: 309702
• Device Lot Number: 5331880
• 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: 03/30/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2025
• 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