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	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation one sample was provided to our quality team for investigation.Upon inspection, the claws of the injector were broken, preventing the device from properly engaging with a mating component.Functional testing was performed, the needle was intentionally exposed and liquid was passed from a syringe through the injector.No issues were observed during these evaluations, liquid moved through the product without issue and no evidence of an obstruction was identified.A device history review was performed for reported lot 2410001, no deviations or non-conformance's were identified during the manufacturing process that could have contributed to this reported issue.Product undergoes a series of inspections throughout the manufacturing process to ensure the quality and functionality of the device, including flow rate verification, no issues related to the reported incident were found.Retained samples of the reported lot were used for additional evaluation.The samples were functionally tested and, in all cases, flow was observed and the product performed as intended.Based on the sample evaluation and our quality team's investigation, we are not able to identify a root cause related to our device our manufacturing process at this time.It is likely the injector claws broken as a result of engaging/disengaging the device.To date, there have been no other similar events reported for this lot.Complaints received for this device and reported will continue to be monitored by our quality team for signs of emerging trends.
Event or Problem Description
Verbatim: post investigation findings showed damage to the safety sleeve of the jaws.Needle of sample was not exposed.

• 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: 22216054
• Report Number: 3003152976-2025-00279
• Device Sequence Number: 20987616
• Product Code: ONB
• UDI-Device Identifier: 00382905150036
• UDI-Public: (01)00382905150036(11)241014(17)270331(10)2410001
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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
• Report Date (Section B): 06/16/2025

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: 2410001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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