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

Catalog Number	300912
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
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 10ml ll eurographics had pump incompatibility.Commercial reference: (b)(4) lot number: 5287155 date of occurrence: 30/03/2026.Description of incident: it was reported that the nurse tried to inject medication into a central line using a 10ml syringe connected to an electric syringe pump.The syringe pump was quickly occluded.This is a recurring problem.No problem with 20ml syringes.Consequences: loss of time for the nurses and risk of infection due to increased handling on one approach.Action taken: change syringe to 20ml the device is not available for expert appraisal.

• 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: 24987100
• Report Number: 1213809-2026-00219
• Device Sequence Number: 10491209
• Product Code: FMF
• UDI-Device Identifier: 00382903009121
• UDI-Public: (01)00382903009121(11)251014(17)300930(10)5287155
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

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: 5287155
• 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: 03/30/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2025
• 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