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

Catalog Number	515005
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported leakage.Event description: this is a complaint about leaking injector section.Leakage from the injector part was observed during preparation.Requested confirmation if it was a product or technique problem.No patient harm.
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.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: one injector assembled with a syringe was provided for investigation.The product was visually inspected, no damage or defects were observed within the device or device components that could have contributed to the reported leak.Functional testing was performed in attempt to recreate the reported event.During these evaluations, liquid moved from the syringe through the injector without issue, and no leakage from the injector or any of the connected components was observed.A device history review was performed for reported lot 2410007, no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported event.Based on our quality team's investigation and given no leakage was identified within the returned product, a root cause cannot be established at this time.Complaints received for this device and the reported condition will be monitored by our quality team for signs 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: 22631062
• Report Number: 3003152976-2025-00397
• Device Sequence Number: 7994389
• Product Code: ONB
• UDI-Device Identifier: 00382905150050
• UDI-Public: (01)00382905150050(11)241018(17)270331(10)2410007
• 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
• Report Date (Section B): 09/03/2025

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: 515005
• Device Lot Number: 2410007
• 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: 09/03/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown