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

Catalog Number	300912
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe 10ml ll eurographics had an issue with volumetric accuracy.The following information was provided by the initial reporter: device reference: 300912.Number of cases: 1.Batch: 5163315.Date of incident: (b)(6) 2025.The notifier reports a defect in the product: luer lock syringe 3 pieces 10ml sterilized by gamma radiation (plastipak), ref 300912, lot 5163315 "we prepare chemotherapy bags by drawing the cytotoxic drug using 10ml syringes.Several times, analytical tests of the chemotherapy bags have revealed non-conformities, leading to the destruction of the bags.After checking the volumes of the 10ml syringes: when filled to the 10ml graduation mark, they contain only 9.77mg of water, i.E., 9.77ml.This inaccuracy causes errors of more than 10% in some preparations and forces us to discard our bags." production problem? corrective measures: destruction of bags due to inaccuracy, preparation of new bags.Clinical consequences: no victims.In view of an expert assessment, the results of which we would like to know as soon as possible, we are keeping two of the devices in question (one incriminated and one new from the same batch) at the brabois hospitals pharmacy.We will ask you to arrange for the return of this device.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - volumetric accuracy.Two samples of 10 ml luer-lok syringes (part number 300912), batch 5163315, were received for evaluation¿one in sealed packaging with complete product information and one received loose.Both samples underwent volumetric accuracy testing and met acceptable performance limits.The observed condition is acceptable per product specifications.Additionally, a device history record review was completed for the provided lot number 5163315.This review identified no rejected inspections or quality issues during production that could have contributed to the reported defect.Complaints received for this device and the reported condition will continue to be tracked and trended.Relevant information will be captured in trend reports and monitored on a monthly basis.The collected data are regularly reviewed by the business team 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: 23581956
• Report Number: 1213809-2025-00725
• Device Sequence Number: 9398746
• Product Code: FMF
• UDI-Device Identifier: 00382903009121
• UDI-Public: (01)00382903009121(11)250612(17)300531(10)5163315
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2026

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: Health Professional
• Device Catalogue Number: 300912
• Device Lot Number: 5163315
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown