MAUDE Adverse Event Report: BECTON DICKINSON INJECTOR LUER LOCK N35C BNS; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515086
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
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: according to the customer report infusion set or injector part found to be damaged during use.Additional information: anticancer drug used -irinotecan lot for zat component 2412141c.Nurse's opinion the injector connection is damaged it seems that it may have been caused by a mishandling.
Additional Manufacturer Narrative
Follow up mdr supplemental for correction.(see d tab).H4.Device manufacture date: 06/19/2024.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: one sample was provided to our quality team for investigation.Upon evaluation, the injector is observed to be incorrectly engaged with the mating connector, noting that the grips of the injector are broken.A device history review was performed for lot 2407013.No deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device.Testing results were reviewed for the reported lot and found all product met required specifications.Based on the available information, we are unable to identify a root cause related to the manufacturing process at this time.It appears that this incident was due to excessive force during connection/disconnection of the device.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: INJECTOR LUER LOCK N35C BNS
• 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: 21960958
• Report Number: 3003152976-2025-00191
• Device Sequence Number: 9274265
• Product Code: ONB
• UDI-Device Identifier: 30382905150051
• UDI-Public: (01)30382905150051(11)240619(17)261231(10)2407013
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 06/18/2025

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: 515086
• Device Lot Number: 2407013
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: Not provided; 06/18/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 05/21/2025; 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown