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

Catalog Number	309649
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
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: it was reported once again, we have discovered a batch of syringes that are not completely sealed or glued, which means that they are open and therefore not sterile.Up to 20 syringes per unit were found to be defective.
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 for device evaluation.Twenty samples of 5 ml eurographic syringes (part number 309649, batch 4297890) were evaluated, and all were found with open seals lacking grid patterns, ranging from three inches to half the package.This condition is non-conforming to product specifications.A requalification for the open seal defect was performed during production, and the line was cleared; however, a limited number of defective pieces may have escaped detection.The potential root cause is linked to the packaging process.Corrective actions will include re-educating all associates involved in manufacturing this batch and issuing a quality alert to the plant.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
(b)(4)- supplemental mdr - package damaged / defective / other.Twenty samples of 5 ml eurographic syringes (part number 309649, batch 4297890) were evaluated, and all were found with open seals lacking grid patterns, ranging from three inches to half the package.This condition is non-conforming to product specifications.A requalification for the open seal defect was performed during production, and the line was cleared; however, a limited number of defective pieces may have escaped detection.The potential root cause is linked to the packaging process.Corrective actions will include re-educating all associates involved in manufacturing this batch and issuing a quality alert to the plant.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: 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: 23550234
• Report Number: 1213809-2025-00717
• Device Sequence Number: 9775244
• 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: GM
• 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,Followup
• Report Date (Section B): 12/16/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 12/10/2025; 12/10/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/16/2025; 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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