MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA CONNECTING SET (C83-O); CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515629
Medical Device Problem Codes	Leak/Splash (1354); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
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: this is a complaint about the injector and spike port came off during outpatient use.This incident involves a white injector and spike port detachment.Leakage of anticancer medication occurred, but the drug name is unknown.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Pr (b)(4) follow up mdr for device evaluation: two samples were provided to our quality team for investigation.Through visual inspection, no damage or defects can be observed on any of the components that may have lead to the reported disconnection.Functional testing verified the injector was able to securely attach to the spike port adapter without any issues.Dimensional testing confirmed that the all-critical dimensions met all required specifications.A device history review was performed for lot 2506603; no deviations or non-conformances were identified during the manufacturing process that could have contributed to this concern.Product undergoes a series of visual and functional evaluations throughout the manufacturing process.Records were reviewed for the reported lot and no issues related to this failure were identified.Based on the available information, we were unable to identify a root cause linked to our device or the manufacturing process at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD PHASEAL¿ OPTIMA CONNECTING SET (C83-O)
• 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: 23884024
• Report Number: 3003152976-2025-00689
• Device Sequence Number: 4706522
• Product Code: ONB
• UDI-Device Identifier: 00382905156298
• UDI-Public: (01)00382905156298
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K250059
• 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: Other
• Device Catalogue Number: 515629
• Device Lot Number: 2506603
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown