MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL; LUER LOCK CONNECTOR (C35)

Catalog Number	515200
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
Subsequent event details provided state that the leak occurred between the injector and the syringe.Manufacturer report # 3003152976-2025-00692 is to be void.The updated event is captured in manufacturer report # 3003152976-2025-00691.

• Brand Name: BD PHASEAL
• Common Device Name: LUER LOCK CONNECTOR (C35)
• 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: 23922443
• Report Number: 3003152976-2025-00692
• Device Sequence Number: 9012738
• Product Code: ONB
• UDI-Device Identifier: 00382905152009
• UDI-Public: (01)00382905152009
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123213
• 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: 515200
• Device Lot Number: UNKNOWN
• 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
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown