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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. Phaseal Optima; Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
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BECTON DICKINSON, S.A. Phaseal Optima; Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System Back to Search Results
Catalog Number 515060
Medical Device Problem Code No Flow (2991)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/06/2026
Type of Reportable Event Malfunction
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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.
cr mequinenza
s/n
fraga, huesca 22520
SP   22520
Manufacturer Contact
helen cox (mdr)
75 north fairway drive
vernon hills, IL 60061
8473935694
MDR Report Key25895199
Report Number3003152976-2026-00338
Device Sequence Number9967122
Product Code ONB
UDI-Device Identifier00382905150609
UDI-Public(01)00382905150609(11)260312(17)280229(10)2603410
Combination Product (Y/N)N
Initial Reporter CountryBE
PMA/510(K) Number
K181221
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source Foreign,Company Representative
Initial Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date (Section B) 08/31/2026
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 Number515060
Device Lot Number2603410
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer08/19/2026
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/06/2026
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date07/21/2026
Supplement Report FDA Received Date08/31/2026
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured03/12/2026
Is the Device Labeled for Single Use? (Y/N) Yes
Usage of Device Initial
Patient Sequence Number1
Patient SexUnknown
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