MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD LUER-LOK PRECISIONGLIDE; PISTON SYRINGE

Catalog Number	309642
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe 10ml ll w/ndl 21x1 rb had leakage past the stopper.The following information was provided by the initial reporter: material # 309642 batch # 3264115 verbatim: rcc received a complaint via email.Email(s) attached.We have received a quality complaint on product sold to our customer.Please contact the customer and cc ****on any future communication.Injuries or adverse event: no item: 309642 quantity affected: (b)(4).Serial/lot number: (b)(6).(b)(4).Are any samples available for return? yes.Reported issue: customer william harding called in to report the medication is leaking from the plunger, like it is not sealed correctly.
Additional Manufacturer Narrative
If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation results: samples were received by our quality team for evaluation.The samples were sent for testing and analysis and nine of them failed testing and had fluid past the front rib of the stopper; therefore, the reported incident could be verified.A device history record review found no non-conformances associated with this issue during production of this batch.Based on the quality team's investigation, the root cause can be traced to the manufacturing process.Actions have been put in place to mitigate this failure.The reported batch (3264115) was manufactured prior to the implementation of the action plan.This incident has been added to our database of reported incidents.
Event or Problem Description
No additional information.

• Brand Name: BD LUER-LOK PRECISIONGLIDE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22670622
• Report Number: 9614033-2025-00079
• Device Sequence Number: 14426216
• Product Code: FMF
• UDI-Device Identifier: 00382903096428
• UDI-Public: (01)00382903096428(10)3264115
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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: 309642
• Device Lot Number: 3264115
• 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: 07/08/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown