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

Catalog Number	515060
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd protector p13-o had leakage between the protector and the vial.The following information was provided by the initial reporter: it had been reported that there had been medication leakage from the vial and protector insertion site while using p13-o.(01/29-2026-neha prasad) please confirm if the protector is assembled manually or using the assembly fixture? what medication was being used during this event? was there any user harm? --a jig was used, but it is unclear if it was used for the appropriate chemical agent.The chemical agent is diforta.The user was not harmed.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: one protector assembled with a vial was provided to our quality team for investigation.Upon inspection, it was observed the stopper was pushed inside the vial.Further evaluation identified the spike tip was damaged as it pierced the metal cap of the vial rather than the rubber stopper.This created a tear within the stopper, pushing it into the vial, which resulted in the leak reported.All products undergo visual and functional inspections throughout the manufacturing process to ensure device quality and performance, including verification that all critical dimensions meet specification.As the lot involved in this incident is unknown, a device history review cannot be performed.Based on our investigation, no product- or process-related issues were identified.The event was determined to have resulted from improper assembly between the protector and vial.Complaints for this device and the reported condition will continue to be tracked and trended.Our quality team routinely reviews collected data to identify any emerging trends.

• 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 ; 8473935694
• MDR Report Key: 24241974
• Report Number: 3003152976-2026-00040
• Device Sequence Number: 18446644
• Product Code: ONB
• UDI-Device Identifier: 00382905150609
• UDI-Public: (01)00382905150609
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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: 515060
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown