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

Catalog Number	309649
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
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 the bd syringe 5ml ll euro 125 s/c package was damaged / defective.The following information was provided by the initial reporter: when did the incident occur? unknown.It was reported that customer have found a number (9) of primary packaging units of bd 5 ml syringes with luer lock tips, ref.309649, that are not (properly) sealed.The plastic is not ¿stuck¿ to the paper, which means that sterility can no longer be guaranteed.This concerns batch no.4297890, (exp.30/09/2029).I have the syringes in question on my desk, so we can send them to bd if necessary.I would appreciate hearing what you expect me to do in this matter.
Additional Manufacturer Narrative
(b)(4) follow up it was reported that the primary packaging was not properly sealed.To support the investigation, two photographs of 5ml eurographic syringes from lot 4297890 were provided to the quality team for evaluation.Both photographs depict one package from different angles, each showing an open seal.This condition is non conforming per product specifications and is associated with the packaging process.A device history record review was completed for material number 309649, lot 4297890.The review confirmed that all visual inspections were performed in accordance with requirements, and no quality notifications related to the reported condition were identified.The lot was inspected and accepted per the inspection control plan and subsequently approved for shipment.A requalification for the open seal defect was performed during production, and the line was cleared of defects.However, it remains possible that a limited number of units with this condition escaped detection.As a corrective action, the personnel involved in manufacturing this lot will be re educated, and a quality alert will be issued to the manufacturing site.

• 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: 23953912
• Report Number: 1213809-2025-00805
• Device Sequence Number: 10550399
• Product Code: FMF
• UDI-Device Identifier: 00382903096497
• UDI-Public: (01)00382903096497(11)241023(17)290930(10)4297890
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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: 309649
• Device Lot Number: 4297890
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 01/04/2026
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown