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	01/13/2026
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 p20-o had a broken spike.The following information was provided by the initial reporter: we received initial notification via email only.Detailed information will be available on (b)(6).Since the product recall will also take place on (b)(6), it will take more than a week from the initial report to the shipment of the replacement product.Additional information - 1st item: using an assembly fixture, i tried to attach a protector 515064 to a carboplatin vial.In that state, when i operated the handle of the assembly fixture, the protector ventilation needle broke.(in particular, it was confirmed that there was no feeling of the protector's ventilation needle getting caught in the aluminum cap of the vial.) the ventilation needle does not penetrate the rubber stopper of the vial, so there is no contamination of carboplatin (anticancer drug).2nd item: using an assembly fixture, i tried to attach a protector 515064 to a carboplatin vial.When the protector's claw touched the aluminum cap of the vial, the protector's claw was damaged.(the protector's nail was damaged before the protector's ventilation needle stuck into the vial's rubber stopper, so there was no contamination of the anticancer drug.) the batch number is 2504404.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
Pr (b)(4) follow up mdr for device evaluation: two protectors were provided to our quality team for investigation.Visual inspection identified that the spike was broken on both units, and damage to the clips that secure the protector onto the vial was observed on one protector, verifying the reported incident.A device history review was performed for reported lot 2504404; no deviations or non-conformances were identified during the manufacturing process that could have contributed to this observation.Retained samples of the reported lot were used for additional evaluation.The product was thoroughly inspected and no damage or defects were observed.Functional testing was performed; in all cases the protectors were properly fitted to the vial without issue and no damage to the spike or vial clips occurred.Product is visually and functionally tested throughout manufacturing according to procedure, ensuring the quality and functionality of the device, including verification that all critical dimensions are within specification, no issues related to the reported issue were noted.Based on the results of this investigation, no root cause related to the manufacturing process could be identified at this time.To date, there have been no other similar events reported for this lot.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.
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: 24242228
• Report Number: 3003152976-2026-00041
• Device Sequence Number: 10175190
• Product Code: ONB
• UDI-Device Identifier: 00382905150647
• UDI-Public: (01)00382905150647(10)U
• 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,Followup
• Report Date (Section B): 03/25/2026

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: 515065
• Device Lot Number: 2504404
• 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: 01/13/2026
• Supplement Date Received by Manufacturer: Not provided; 03/25/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/06/2026; 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown