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

Catalog Number	300912
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
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 10ml ll eurographics had leakage past the stopper.The following information was provided by the initial reporter: syringes are leaking (art 300912 and 305959).When did the incident occur? = during use.It is reported that we have received another complaint about leaking syringes.The customer has been purchasing the 10 ml syringes with two bd reference numbers for a long time: (b)(4).It is mainly the syringes with reference number (b)(4) (us-made) that leak.This time, it concerns 5 boxes of (b)(4) with lot number 5167909.We would like to receive an urgent solution to this problem and a credit note for the 5 boxes that the customer received.Since these syringes are contaminated with biological material, they are immediately discarded.Therefore, we have no samples.Additional information provided: "when our client was aspirating bacterial cultures (in medium) the liquid immediately ended up behind the plunger.".
Additional Manufacturer Narrative
(b)(4) supplemental mdr leakage past stopper one photo of a 10 ml luer lock syringe (part number 300912) was received and reviewed.The image shows a fully assembled syringe with an unidentified yellowish fluid between the plunger rod and the stopper; however, no visible defects can be confirmed from the photo alone.A physical sample is needed to conduct a more detailed evaluation and determine the potential root cause of the condition.A device history record review for material number 300912, lot 5167909, confirmed that all in process and final inspections were completed as required, with no quality notifications related to the reported issue.The lot met all acceptance criteria per the inspection control plan, was approved for shipment, and is compliant with applicable product specifications.We appreciate you bringing this observation to our attention.Complaints for this device and reported condition will continue to be tracked, trended, and reviewed monthly to identify any emerging trends.
Event or Problem Description
No additional information was provided.

• 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: 23838608
• Report Number: 1213809-2025-00789
• Device Sequence Number: 21290930
• Product Code: FMF
• UDI-Device Identifier: 00382903009121
• UDI-Public: (01)00382903009121(11)250616(17)300531(10)5167909
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 02/03/2026

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: Health Professional
• Device Catalogue Number: 300912
• Device Lot Number: 5167909
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown