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	02/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe 5ml ll euro 125 s/c package was damaged / defective.Supplier reference: 309649.Lot no.: 5317381.Incident date: 02/17/2026.It was reported that "during use, a sealing defect was observed on the syringe packaging, which was not completely sealed.In addition, the pre-cuts were poorly made.This anomaly only affects a few units in the box".
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.A sealing defect was reported on the syringe packaging.To support the investigation, the quality team received and evaluated two photographs of 5ml eurographic syringe packages.The images, taken from different angles, show a strip containing multiple sealed packages with no separation between adjacent packages.This condition is nonconforming to the product specification and is attributable to the packaging process.A device history record review was completed for material number 309649, lot 5317381.The review confirmed that all required visual inspections were performed in accordance with established requirements, and no quality notifications were identified related to the reported condition.The lot was inspected and accepted per the approved inspection control plan, released for shipment, and is considered compliant with product specification requirements based on the inspections performed.Based on the investigation and photographic sample assessment, the condition reported by the customer 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: 24546300
• Report Number: 1213809-2026-00107
• Device Sequence Number: 5725333
• Product Code: FMF
• UDI-Device Identifier: 00382903096497
• UDI-Public: (01)00382903096497(11)251113(17)301031(10)5317381
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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: 5317381
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2025
• 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