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

Catalog Number	300912
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe 10ml ll neurographic plunger rod was broken / damaged.The following information was provided by the initial reporter translated from french to english: ref : mv25-47.Please find enclosed a material safety report sent to ansm, concerning a 10 ml luer lok bd syringe, reference (b)(4), lot number 4347922.The device is being held at the pharmacy pending your return conditions.Description of facts: " when returning blood to an implantable chamber, the plunger detaches from the syringe.Risk for the patient of an air bubble (risk of embolism)¿.Additional information provided: response received: has the patient or user suffered any harm? no, but risk of embolism we've been told that samples are available for investigation.Could you please specify whether the samples are.Used (during or after use) with saline solution.Important: if used, please confirm whether the samples are contaminated with blood or cytotoxic drugs.We send the device to our logistics platform.One of my colleagues will contact you to arrange the return of the device.I remain at your disposal if necessary.
Additional Manufacturer Narrative
If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - plunger rod broken / damaged.One sample of the 10 ml eurographic syringe from batch 4347922 was received and evaluated.The reported defect was not observed in the sample provided.The condition observed is acceptable per product specification.Furthermore, a device history record review was completed for provided lot number 4347922.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• 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: 21869603
• Report Number: 1213809-2025-00288
• Device Sequence Number: 7916646
• Product Code: FMF
• UDI-Device Identifier: 30382903009122
• UDI-Public: (01)30382903009122(11)241212(17)291130(10)4347922
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

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: 4347922
• 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: 04/03/2025
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown