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

Catalog Number	309658
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
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 3ml ll euro 200 s/c had visible silicone.The following information was provided by the initial reporter: multiple sku w/ visible particles, defective plungers, excessive lubricant when did the incident occur? before use.Please note that we have identified several quality defects in the syringes received under po: (b)(4).The issues observed include: visible particles inside the syringe, particles between the plunger and barrel space, multiple white particles found inside the packaging, defective plungers, excessive lubricant.The details of the rejected items can be found in the table below, and supporting photographs are attached for your reference.Ref no.Description size lot no qty received total qty received in pcs qty rejected % 309658, bd plastipak syringe, 3ml 5015070, 5box=1000, 1000, 89, 8.9%, 309658, bd plastipak syringe, 3ml 4352867, 1box=200, 200 26, 13.0%.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation.A report was received indicating the presence of visible particles, defective plungers, and excessive lubricant in 3ml luer-lok syringes.To support the investigation, ninety-six syringe samples and two photographs were submitted to the quality team for evaluation.All samples arrived in sealed blister packaging, with seventy units from lot 5015070 and twenty-six from lot 4352867.Upon inspection, ninety-one samples exhibited no observable defects.However, two samples showed excessive silicone, two contained an unidentified dark foreign material within the packaging, and one syringe displayed a torn stopper.No foreign matter was observed within the fluid path of any of the samples.One of the submitted photographs depicted a syringe in sealed packaging with the stopper not securely attached to the plunger rod.The second photograph showed the top web side of the blister packaging, including all relevant product information from lot 5015070.The conditions observed are non-conforming to product specifications and appear to be related to the assembly process.A device history record review was conducted for material number 309658, covering lots 5015070 and 4352867.The review confirmed that all visual inspections were performed in accordance with established requirements, and no quality notifications were associated with the reported condition.Both lots were inspected and accepted per the inspection control plan, approved for shipment, and deemed compliant with product specification requirements.

• Brand Name: BD PLASTIPAK 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: 22779210
• Report Number: 1213809-2025-00528
• Device Sequence Number: 18353024
• Product Code: FMF
• UDI-Device Identifier: 00382903096589
• UDI-Public: (01)00382903096589
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 10/08/2025

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: Health Professional
• Device Catalogue Number: 309658
• Device Lot Number: UNKNOWN
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown