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

Catalog Number	515086
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the needle popped out of injector.Event description: when i tried to remove the injector after dosing, the needle popped out.
Additional Manufacturer Narrative
Follow mdr for correction, see d tab.Medical device catalog 515086.Medical device lot 2407013.
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.Through visual inspection, the hook of the safety sleeve is observed to be broken the injector needle was exposed, verifying the reported incident.A device history review was performed for reported lot 2407013, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this observation.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, no issues related to this incident were found.It is important to grip the white injector components when engaging/ disengaging; do not grip the blue safety sleeve.If the safety sleeve grips become dislocated, the injector is activated causing needle exposure.To prevent damage to the handles of the safety sleeve, the injector must be removed by pulling it backwards and must not be forcefully engaged.The instructions for use must be carefully followed when using phaseal devices in order to avoid any damage to the product that may result in the device not functioning as intended.Based on our sample evaluation, it was determined that needle became exposed due to the 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.
Event or Problem Description
No additional information.

• Brand Name: INJECTOR LUER LOCK N35C MULTIPACK
• 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: 22629958
• Report Number: 3003152976-2025-00394
• Device Sequence Number: 9074124
• Product Code: ONB
• UDI-Device Identifier: 00382905150050
• UDI-Public: (01)00382905150050
• 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): 12/11/2025

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: Not provided; 12/10/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 08/12/2025; 12/10/2025
• 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