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	05/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
User was using injector luer lock (n35) for reconstitution of chemo drug and realized leaking from the luer lock.
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.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: one video was provided to our quality team for investigation.Through visual inspection, liquid is observed to be leaking from the injector.It was noted, when the plunger was pressed on the syringe, the injector was not properly engaged with a mating component.As a result, this creates pressure within the device, causing damage to the internal components and eventually leading to the leakage as observed within the video.A device history review was performed for reported lot 2304004, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Retained samples of lot 2304004 were used for additional evaluation.Dimensional testing was performed on the injectors , including the luer thread, verifying all critical dimensions are within specification.Leakage and pressure testing is performed for all lots during manufacturing to ensure the quality of the membrane.Results were reviewed for the reported lot and verified to be within specification.Based on our quality team's investigation and video evaluation, this incident likely occurred as a result of improperly engaging the device as the injector must be connected to a mating component when pressing on the syringe plunger to properly open the fluid path and allow liquid to flow.It is important to follow the instructions for use when using phaseal devices to ensure the product functions properly.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.

• 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 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19310552
• Report Number: 3003152976-2024-00289
• Device Sequence Number: 3076704
• Product Code: ONB
• UDI-Device Identifier: 00382905150036
• UDI-Public: (01)00382905150036
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K140591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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 Expiration Date: 09/30/2025
• Device Catalogue Number: 515003
• Device Lot Number: 2304004
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown