MAUDE Adverse Event Report: BECTON DICKINSON INJECTOR LOCKING N40-O; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515056
Medical Device Problem Codes	Leak/Splash (1354); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that there was separation.Event description: material: 515056.Batch: 2410301.Locking optima injector un-luer locking from the curlin administration sets (ref #(b)(4)).This occurred while the patients were at home.Chemo spill in home, did not complete therapy.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Additional information i know of 3 occurrences over the past several weeks swivel attachment is detaching from line.What kind of chemo drug was used? 5 fluorouracil 5ml per hr, no errors prior to disconnection have you replaced the defective product and successfully completed the medication procedure? yes.
Additional Manufacturer Narrative
Investigation results: no photographic evidence or physical samples were provided to investigate the reported condition.A thorough review of the device's history was conducted for optima injector n40-o lot 2410301, and no deviations or non-conformances were found during the manufacturing process that could have contributed to the issue.Three retained samples were received for further evaluation, a visual inspection was done on all retained injector samples and no damage or anomalies were identified.The retained n40-o injector samples were measured by the quality metrology team.Based on the metrology testing performed, no anomalies were detected in the retained samples that could result in luer lock disconnection.The product undergoes inspections at various stages of the manufacturing process to ensure its quality and functionality.Based on the information available, we are currently unable to identify a root cause related to the manufacturing process.Our quality team will continue to monitor complaints received for this device and the reported condition for any potential emerging trends.

• Brand Name: INJECTOR LOCKING N40-O
• 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: 22947918
• Report Number: 3003152976-2025-00489
• Device Sequence Number: 18427281
• Product Code: ONB
• UDI-Device Identifier: 00382905150562
• UDI-Public: (01)00382905150562(11)241014(17)270331(10)2410301
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K201099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

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: 515056
• Device Lot Number: 2410301
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown