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

Catalog Number	309658
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe 3ml ll euro 200 s/c barrel cracked.The following information was provided by the initial reporter: code: seringe 3 piece luer lock 03ml reference : 309658 batch number : nr expiry date : nr medical device kept : no number of product concerned : 1 date of event : 25/09/2025 place of event : pharmacy (cytotoxic reconstitution unit) ansm declaration: no description of the event : the 3 ml syringe which punctured/split during the preparation of vidaza (in the isolator).The cytotoxic agent had to be discarded, the preparation redone and the isolator cleaned.Consequence: loss of the vial of vidaza, loss of time.
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) follow up it was reported that a 3 ml syringe split during preparation.To support the investigation, two photographs of a 3 ml luer-lok syringe were provided for evaluation by the quality team.The images show different angles of a fully assembled syringe with a significant crack on the barrel, specifically in the area without scale markings.Although the crack is not clearly visible in the photographs, its presence is indicated by multiple bubbles originating from that section of the syringe.This condition is non-conforming to product specifications and appears to be related to the assembly process.Because the lot number was reported as ¿unknown,¿ the defective rate cannot be determined.A batch number is required to assess whether corrective actions are necessary.Based on the information currently available, no corrective actions will be implemented.

• Brand Name: BD PLASTIPAK 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: 23335256
• Report Number: 1213809-2025-00658
• Device Sequence Number: 18795707
• Product Code: FMF
• UDI-Device Identifier: 00382903096589
• UDI-Public: (01)00382903096589
• 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): 12/01/2025

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: 309658
• Device Lot Number: UNKNOWN
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown