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

Catalog Number	515629
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
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 fluid leaked out from the infusion bag fitted with the optima spike.Iv line connection kit used in combination with the spike.While administering infusion by attaching the optima spike to the infusion bag and connecting it to the optima iv line connection kit, the fluid leaked out of the infusion bag and transmitted to the infusion set.The actual product is still in use by a patient and is scheduled for recall at a later date.Can we confirm with the customer, was the leak between the spike of the connector and the iv bag? unknown: the leak was discovered when 515629 was connected to 515628, and anticancer drugs were transferred to the hospital infusion set connected to 515629.Anticancer drug contamination.The hospital did not confirm the location of the leak.What brand iv bag was being used? otsuka pharmaceutical glucose 500ml.Was the spike fully inserted when the leak was observed? inserted.Was there any patient or user impact? yes.If yes, please describe: patient treatment delayed (the planned amount may have not been administered.The amount of leakage was confirmed; it was determined to be minimal and not a problem for treatment.) patient and medical staff exposure to anticancer drugs was due to the anticancer drug leak.

• Brand Name: BD PHASEAL¿ OPTIMA CONNECTING SET (C83-O)
• Common Device Name: CLOSED ANTINEOPLASTIC AND 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: 23424477
• Report Number: 3003152976-2025-00595
• Device Sequence Number: 15902255
• 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): 04/26/2026

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: 515629
• Device Lot Number: 2506603
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 04/26/2026
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 04/26/2026
• 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