MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD Phaseal Optima; Closed antineoplastic and hazardous drug reconstitution and transfer system

Catalog Number	515070
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was provided by the initial reporter: customer advised that there was a leak of azacitdine when being delivered via subcutaneous injection from phaseal optima to needle connection.Advised that they put connector into injector then added needle to connector.Provided education of the order in which it needs to be connected- needle into connector then connector into injector additional information: the leak occurred after assembling and when the therapy was being administered.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: BD Phaseal Optima
• Common Device Name: Closed antineoplastic and hazardous drug reconstitution and transfer system
• 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 ; +1(847)393-5694
• MDR Report Key: 50802865
• Report Number: 3003152976-2026-00433
• Device Sequence Number: 12910706
• Product Code: ONB
• UDI-Device Identifier: 00382905150708
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181221
• 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
• Report Date (Section B): 09/04/2026

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: 515070
• Device Lot Number: 2511501
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown