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	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.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 connector c35-o had leakage at the luer, the following information was provided by the initial reporter: material # 515070 and 515056 batch # unknown complaint via email.Email(s) attached i am not sure if you are the one who can help me with this, but i would like an inservice on the phaseal for my unit as there still seems to be some issues with leakage that i think is related to user error.I feel like an in-service will help with the issues we are experiencing.Let me know if you can help me with this.I appreciate you! per full email: i wanted to send out this education again to help keep everyone safe.I have included all rns for situational awareness and many of you are not chemotherapy providers yet but are going through the oncology tips program so it will be good information for the future.Situation: we have experienced a few additional chemotherapy disconnections and spills on our unit involving phaseal connectors since our previous education was shared.Background: over the past year, there have been multiple documented chemotherapy spills related to phaseal connector use.Education was previously provided after consultation with bd product educators regarding proper connection technique.Assessment: review of recent events continues to show that disconnections can occur during nursing connections to the phaseal system, emphasizing the importance of consistent use of the correct attachment method.Recommendation: we wanted to send a reminder on the proper method for attaching the phaseal connector and ask that you please review the attached handout.If a spill does occur, please submit an hrp and an arc product concern.Key steps for a secure connection include: â· fully insert the tubing post into the phaseal adapter.Turn it a quarter turn before securing with the luer lock.Before locking, gently pull on the tubing to confirm the connection is secure.We will also be reaching out to the bd representative again to coordinate a visit to holy family for additional hands-on education and training.
Additional Manufacturer Narrative
(b)(4) follow up report for correction.This was determined to be an incorrect entry after the mdr was submitted.
Event or Problem Description
As per additional information provided by customer, leakage did not occur at the connector.

• 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: 24884393
• Report Number: 3003152976-2026-00179
• Device Sequence Number: 10494459
• Product Code: ONB
• UDI-Device Identifier: 00382905150708
• UDI-Public: (01)00382905150708
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K181221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

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: UNKNOWN
• 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: 03/23/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown