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

Catalog Number	300912
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
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 a volumetric accuracy problem.The following information was provided by the initial reporter: name: ser 3p verrou 10 ml, catalogue number: 300912, lot number: 5006307, date of occurrence: (b)(6) 2025.Description of the facts: the volumes taken with the 10ml ll bd syringes ref 300912 are incorrect.By withdrawing 10ml with this model of syringe, this corresponds to 9.7ml contrary to other syringes (in particular the 10ml bd non-ll syringes, ref 307736, batch 2501119).Clinical consequences observed: risk of under dosing in injectable chemotherapy preparations using 10 ml syringes.Device available for expert appraisal: yes.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - volumetric accuracy three samples and four photos were submitted to the quality team for investigation.Visual inspection revealed no observable defects, and volumetric testing confirmed that all samples met the required specifications.The photos were consistent with the physical condition of the samples.Based on the results of both visual and volumetric assessments, the samples were found to be in compliance with applicable product specifications.Furthermore, a device history record (dhr) review was completed for the provided lot number 5006307.The review showed no rejected inspections or quality issues during production that could have contributed to the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.This information will be captured in trend reports and monitored monthly.Our business team regularly reviews the collected data 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: 22110841
• Report Number: 1213809-2025-00356
• Device Sequence Number: 20626993
• Product Code: FMF
• UDI-Device Identifier: 30382903009122
• UDI-Public: (01)30382903009122(11)250106(17)291231(10)5006307
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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: 5006307
• 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: 05/07/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown