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	08/06/2025
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.The following information was provided by the initial reporter: when did the incident occur? during use "after connecting the syringe to the pump, a leak started from the syringe body.The syringe contained tpn." additional information provided: ¿ is the pump connected to the patient = yes ¿ was patient or user harmed? if yes, please explain = no ¿ was the hcp present when the issue occurred? = yes ¿ if leakage occurred, please confirm the fluid that leaked= tpn ¿ was additional medical intervention/medication required? if yes, please explain ¿ no.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - leakage.Following the connection of the syringe to the pump, a leak was observed originating from the syringe body.To support the investigation, four photos and one sample were submitted for evaluation by the quality team.One image provides a close-up of the carton box label, displaying all relevant product information.Another image captures the top web slip, which includes the applicable product specifications.While the syringe appears identical in both photographs, a prominent crack is visible in the non-scale marking area of the barrel, specifically near the lower end.The consistent location of the damage suggests that both images depict the same unit.Notably, the fluid inside the syringe differs in color between the two photos.A physical sample was inspected and confirmed to exhibit the same crack condition as observed in the photographs.This condition does not conform to product specifications and is attributed to the assembly process.A review of the device history record was conducted for material number 300912, lot 5083084.The review confirmed that all visual inspections were performed in accordance with established requirements, and no quality notifications were recorded related to the reported condition.The lot was inspected and accepted based on the inspection control plan, approved for shipment, and deemed compliant with product specification requirements.To date, no similar events have been reported for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured in trend reports and monitored monthly.Our business team regularly reviews the collected data to identify 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: 22857086
• Report Number: 1213809-2025-00563
• Device Sequence Number: 9230808
• Product Code: FMF
• UDI-Device Identifier: 00382903009121
• UDI-Public: (01)00382903009121(11)250324(17)300228(10)5083084
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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): 10/30/2025

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: 300912
• Device Lot Number: 5083084
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown