MAUDE Adverse Event Report: BECTON DICKINSON, S.A. Phaseal Optima; Closed antineoplastic and hazardous drug reconstitution and transfer system

Catalog Number	515070
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was provided by the initial reporter: it was reported that anticancer drugs were administered via a c35-0 attached to a safe t cannula, which was selected for compatibility with the safe t port.Approximately 30 minutes after the start of administration, the patient exhibited abnormal symptoms.Upon investigation, it was determined that air was entering through the connection point and had entered the patient¿s bloodstream.Although appropriate measures prevented a serious outcome, this was an event that could have led to a life-threatening risk.The c35-0 attached to the safe-t cannula was connected at an angle.While an installation error is highly likely, the possibility of a defect in the c35-0 itself cannot be ruled out, so we would like this to be verified.Additional information received on 25 sep 2026 sales rep mentioned that: it is unclear whether a standalone safe t-port is being connected to another manufacturer¿s iv set or whether an integrated iv set is being used.It¿s possible that the connection was made at an angle.This appears to be primarily a manual error, such as a misalignment during assembly.I didn't check myself, but it seems a nurse who noticed something was wrong checked it.It seems there was no leak, but apparently some air got in.The issue has not yet been resolved.Since there is a possibility of a product defect on the part of bd or cardinal, both companies have been asked to conduct a pir.Meanwhile, the hospital plans to provide training on how to use the device and implement measures to prevent future occurrences.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• 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 ; +1(847)393-5694
• MDR Report Key: 50896547
• Report Number: 3003152976-2026-00453
• Device Sequence Number: 13433040
• Product Code: ONB
• UDI-Device Identifier: 00382905150708
• UDI-Public: (01)00382905150708(11)250710(17)270630(10)2507501
• 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
• Report Date (Section B): 09/09/2026

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: 515070
• Device Lot Number: 2507501
• 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: 09/07/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown