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

Catalog Number	309580
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
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 bd syringe 3ml ll w/ndl 18x1-1/2 rb was found to have leakage.Verbatim: complaint via email.Email(s) attached.A couple of them were defective on the same day.I am the patient and am very skilled at self-injection and have been experiencing issues with these syringes for quite some time now.No serious injury occurred besides having to waste and not able to give myself medication.At this time, i do not have any samples.When using the syringe, i am just very accustomed to put the used needle in the sharpie container resulting in it slipping my mind to save a sample.I do however have the wrapping for one of the syringes in question: lot: 5353717 ref: (b)(4) just last night i had to waste two vials of my iv medication because the syringes were leaking, leaving the medication to become contaminated and useless.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.A physical sample is required for a more thorough evaluation and potential root cause determination.We will continue monitoring the complaint trend for the product and symptom.Batch 5353717 is considered in compliance with our product specification requirements.The complaint was not confirmed, and no capa evaluation was required.This complaint type will continue to be trended within the post-market surveillance process, and any determined escalation will be managed there.

• 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: 24761400
• Report Number: 1213809-2026-00162
• Device Sequence Number: 10299723
• Product Code: FMF
• UDI-Device Identifier: 00382903095803
• UDI-Public: (01)00382903095803(10)5353717
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

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: Lay User/Patient
• Device Catalogue Number: 309580
• Device Lot Number: 5353717
• 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: 03/12/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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