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

Catalog Number	515629
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was provided by the intiial reporter: it was reported that the connection between the injector and the spike port came loose.User reconnected it and continued using the unit as is.Additional information was received on 15 sep 2026: additional information: the information acquisition date was entered incorrectly; the correct date of obtaining information is 9 14.The event occurrence date is 9 8.Follow up performed to verify: what lot was used in this event? is the facility new to using optima has education been provided on connection techniques.Rep mentioned that: unknown implementation began at the end of august.It hasn¿t even been a month yet.A training session has already been held.Additional information provided: a leak has been confirmed.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: BD Phaseal
• 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: 50946161
• Report Number: 3003152976-2026-00461
• Device Sequence Number: 9534259
• Product Code: ONB
• UDI-Device Identifier: 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: 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: 09/08/2026
• Initial Report FDA Received Date: 09/30/2026
• 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