MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL; INJECTOR LOCKING N40-O

Catalog Number	515056
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	11/18/2025
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: during infusion of high-dose melphalan, a minor leak occurs in the connection between the drip tube and connector.The patient receives an estimated one milliliter of chemotherapy on the right upper arm and one milliliter on the sheet.The drip is stopped.The skin is washed abundantly with soap and water and the sheets are changed.After switching with a new connector, melphalanet can be restarted without remark no obvious irritation is noted on the skin.
Additional Manufacturer Narrative
Correction: "dchu met with reps to clarify event details as email responses were conflicting to what was reported.Based on provided information, there was a leakage at the luer connection of the connector and mating tubing.Mating tubing does not belong to bd.There was no clear evidence of a disconnection at the time of the incident, however, upon reviewing the event details with the customer, it is believed they were not using the proper techniques when connecting the devices.Reps went on site and performed additional training to ensure they are fulling connecting the devices.There was not impact to the patient or healthcare professional.There is only one connector lot at this facility, 2508501." cancelling this mdr as all details were provided in mfr # 3003152976-2025-00720 which was submitted for the 2508501 connector lot.
Event or Problem Description
No additional information.

• Brand Name: BD PHASEAL
• Common Device Name: INJECTOR LOCKING N40-O
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24007877
• Report Number: 3003152976-2025-00722
• Device Sequence Number: 18445381
• Product Code: ONB
• UDI-Device Identifier: 00382905150562
• UDI-Public: (01)00382905150562(11)250414(17)270930(10)2504801
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K201099
• 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): 01/14/2026

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: 515056
• Device Lot Number: 2507301
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown