MAUDE Adverse Event Report: BECTON DICKINSON INJECTOR LUER LOCK N35; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515003
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Description of incident: when methotrexate used for ectopic pregnancy was reconstituted with the bd phaseal¿ system injector, reference 515003 and lot unknown, methotrexate was found to flow out of the injector.Indeed, when the nurse tried to remove the injector from the methotrexate vial, liquid flowed around the needle casing.Finally, the nurse used a second injector of identical reference and unknown batch to repeat the procedure, leading to the same incident.The same incident.Opening a third injector of identical reference and unknown batch, the procedure was successfully completed.Clinical consequences: exposure of nursing staff to a hazardous substance methotrexate spillage.To date no clinical consequences have been observed for patients or staff.Actions taken at the plant: opening of 3 injectors and 4 vials of methotrexate.The device is not available for expert appraisal.
Additional Manufacturer Narrative
(b)(6).Follow up mdr for device evaluation: no photos or physical samples that display the reported condition were available for investigation.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device.As the lot involved in this incident is unknown, a device history review cannot be performed, and additional retained samples cannot be evaluated.Based on the available information we are not able to identify a root cause at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
Description of incident: when methotrexate used for ectopic pregnancy was reconstituted with the bd phaseal¿ system injector, reference: 515003 and lot unknown, methotrexate was found to flow out of the injector.Indeed, when the nurse tried to remove the injector from the methotrexate vial, liquid flowed around the needle casing.Finally, the nurse used a second injector of identical reference and unknown batch to repeat the procedure, leading to the same incident.The same incident.Opening a third injector of identical reference and unknown batch, the procedure was successfully completed.Clinical consequences: exposure of nursing staff to a hazardous substance methotrexate spillage.To date no clinical consequences have been observed for patients or staff.Actions taken at the plant: opening of 3 injectors and 4 vials of methotrexate.The device is not available for expert appraisal.Could you confirm if the leak occurred inside the injector plunger or between the injector and the syringe? answer: between the injector and the syringe.

• Brand Name: INJECTOR LUER LOCK N35
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21112230
• Report Number: 3003152976-2025-00005
• Device Sequence Number: 7463072
• Product Code: ONB
• UDI-Device Identifier: 00382905150036
• UDI-Public: (01)00382905150036
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2025

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: 515003
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/05/2025
• 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