MAUDE Adverse Event Report: BECTON DICKINSON, S.A. PHASEAL; UNKNOWN INJECTOR

Catalog Number	515004
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr, if a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Event details: i have a customer who used a connector earlier and it leaked.Per customer response: the leak occurred between the transfer injector and the luer lock syringe.Was the device being used in/on patient when the issue occurred? i believe so yes.Was patient or user harmed? if yes, please explain ¿ not that i am aware of was the hcp present when the issue occurred? yes if leakage occurred, please confirm the fluid that leaked.Vinblastine was additional medical intervention/medication required? if yes, not that i know of.
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 injector luer lock n35c lot 2411727, 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, during visual inspection no deformations, material deficiencies, burrs, or fractures were observed.Luer thread functionality tests were performed on the retained samples, confirming that the product meets its intended performance requirements.All units were confirmed to be in optimal and acceptable condition and the results are in full compliance with the established specifications.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.
Event or Problem Description
No additional information.

• Brand Name: PHASEAL
• Common Device Name: UNKNOWN INJECTOR
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• 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: 23922445
• Report Number: 3003152976-2025-00691
• Device Sequence Number: 18395408
• Product Code: ONB
• UDI-Device Identifier: 00382905150043
• UDI-Public: (01)00382905150043(11)241129(17)270430(10)2411727
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140591
• 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): 01/13/2026

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: 515004
• Device Lot Number: 2411727
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown