MAUDE Adverse Event Report: BECTON DICKINSON, S.A. PHASEAL OPTIMA; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515065
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
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: it was reported that the rubber stopper of the vial came off while using the protector.The protector was attached to the vial using a jig.When an injector was connected to the protector and an attempt was made to inject air, the injection failed.The injector was removed, the transparent cap of the protector was reattached, and the protector was pressed onto the vial again to ensure proper attachment.Then, the injector was connected to the protector, and when the plunger of the syringe connected to the injector was operated, the rubber stopper of the vial fell into the vial.The protector has been removed from the vial because it was necessary to prepare the medication.Upon inspecting the vial, damage was found on the aluminum cap portion, and we have discussed with the hospital representative the possibility that the aluminum cap portion may have been accidentally punctured when the protector was initially attached to the vial using the jig.We also need to clarify, was the protector properly placed within the fixture? it was confirmed that it was attached correctly.When they report, "transparent cap of the protector was reattached" - what is this referring to? after attaching the protector to the vial using a jig, the vial with the protector attached was removed from the jig.Then, the transparent cap on the injector connection part of the protector was removed, and the injector was connected.However, air could not be injected from the injector, so a suspected problem with the attachment of the protector and vial arose.The transparent cap was reattached to the injector connection part of the protector, and the protector was pressed onto the vial again by hand without using the jig.What medication did this occur with? gemcitabine.
Additional Manufacturer Narrative
Correction: complaint determined to be not reportable.Mdr cancelled.
Event or Problem Description
No additional information.

• Brand Name: 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 ; 8473935694
• MDR Report Key: 24020071
• Report Number: 3003152976-2025-00723
• Device Sequence Number: 21071010
• Product Code: ONB
• UDI-Device Identifier: 00382905150654
• UDI-Public: (01)00382905150654(11)250402(17)270228(10)2503742
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181221
• 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): 01/20/2026

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: Other
• Device Catalogue Number: 515065
• Device Lot Number: 2503742
• 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: 12/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown