BD PhaSeal Optima 515079Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00382905150791), received between May 5, 2020 and May 6, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Jun 16, 2025Open, Classified

   Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions for use, which could be an issue if a healthcare professional is prompted to review it.

   Z-2453-2025 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2024Leak/Splash; Leak/Splash

  MATERIAL#: 515079 BATCH#: 2311501 IT WAS REPORTED BY THE CUSTOMER THAT AROUND 1510 WHEN I WAS ABOUT TO START THE TREATMENT, I SAW A DROP OF CHEMO COMING FROM THE PHASEAL ON C100 . I IMMEDIATELY BROUGHT IT TO PHARMACY TO CHANGE MEDICATION. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED WE HAD A SAFETY EVENT REPORTED FOR BD ITEM #S 515079 (PHASEAL OPTIMA INFUSION ADAPTER). LET¿S IDENTIFY THIS AS BD 270, AS A REFERENCE NUMBER. THE DEFECTIVE PRODUCTS IS AVAILABLE FOR PICK UP FROM DEFECT DEPOT. PLEASE CONTACT HECTOR LEAL REGARDING PRODUCT PICKUP FROM DEFECT DEPOT. BASED ON THE INFORMATION PROVIDED BELOW, COULD YOU START A PRODUCT QUALITY REPORT? BD 270: REPORTED DATE: 4/17/2024; EVENT DATE: (B)(6) 2024; ITEM NUMBERS: 515079; LOT NUMBER: 2311501; ITEM AVAILABLE FOR PICK UP?: YES; PICTURE: NO; PATIENT HARM: NONE; AREA: ATC BLUE (ACB): MAYS (AMBULATORY CARE BLDG.). EVENT DETAILS: ¿AROUND 1510 WHEN I WAS ABOUT TO START THE TREATMENT, I SAW A DROP OF CHEMO COMING FROM THE PHASEAL ON C100 . I IMMEDIATELY BROUGHT IT TO PHARMACY TO CHANGE MEDICATION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19247862 ↗
• MalfunctionMar 12, 2024Leak/Splash; Leak/Splash

  MATERIALS#: 515079 BATCH#: UNKNOWN IT WAS REPORTED BY THE CUSTOMER THAT THE PRODUCT IS LEAKING AFTER THEY ATTACH THE PRODUCT TOGETHER. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. THE PRODUCT IS LEAKING AFTER THEY ATTACH THE PRODUCT TOGETHER. 515064; 515056; 515079. PER FOLLOW UP WITH REP: WE HAVE BEEN TO THIS CLINIC AND WORKED WITH THEM ON PROPER USE OF PHASEAL OPTIMA. THEY WERE NOT USING IT CORRECTLY SO IT IS NOT A PRODUCT ISSUE. OUR TEAM TRAINED THE STAFF ON PROPER USAGE MOVING FORWARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18884748 ↗
• MalfunctionSep 30, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ OPTIMA INFUSION ADAPTER (C100-0 MULTI) MEMBRANE WAS MISSING WHEN SPIKING IT INTO THE BAG, CAUSING CHEMOTHERAPY MEDICINE TO LEAK FROM THE TUBING PORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN CHECKING DOSE, DRUG WAS DRIPPING FROM PHASEAL ADAPTER SITE. 5-10 DROPS WAS CAUGHT BY CHEMO MAT. DOSE WAS DISCARDED. NEW DOSE WAS PREPARED FOR PATIENT. PHASEAL LOT NUMBER 2103501. AREA WAS CLEANED. SPILL DOCUMENTED." "THE PRODUCT INVOLVED IS THE C-100-O INFUSION ADAPTER THAT IS SPIKED INTO THE BAG PRIOR TO DISPENSING. THE LEAK CAME FROM THE PORT WHERE THE TUBING IS ATTACHED WHICH HAS A MEMBRANE PRIOR TO SPIKING. THIS ONE APPEARS TO BE DEFECTIVE IN THAT IT WAS MISSING AND THEREFORE CHEMO SPILLED OUT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12556878 ↗
• MalfunctionJun 9, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ OPTIMA INFUSION ADAPTER (C100-0 MULTI) FELL OUT OF THE PACKAGING AND ONTO THE FLOOR WHILE HANGING IT ON THE POLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHASEAL OPTIMA INFUSION ADAPTOR FELL OUT OF THE BAG AND ONTO THE FLOOR AS NURSE WAS GOING TO HANG IT ON POLE.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11969339 ↗
• MalfunctionJul 7, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT INFUSION ADAPTER C100-O MULTI HAD A CHEMO SPILL. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN (PROVIDED C100), BATCH NO: UNKNOWN. IT WAS REPORTED THAT THERE WAS A CHEMO SPILL DUE TO A C100 FALLING OUT OF THE BAG WHILE MIXING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10243240 ↗
• MalfunctionMay 5, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 2 BD PHASEAL OPTIMA INFUSION ADAPTERS (C100-0 MULTI) EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WANTED TO LET YOU KNOW THAT WE¿VE HAD AT LEAST 2 INSTANCES IN WHICH THE C100 HAS FALLEN OUT OF THE BAG CAUSING A CHEMO SPILL, MOST RECENTLY TODAY. BOTH INSTANCES INVOLVED OUR REGULAR PVC BAGS (NOT THE PVC FREE, WHICH ALSO HAS HAD THE C100 FALL OUT). NO THE TWO INSTANCES I MENTIONED THE BAGS WERE NOT WERE NOT REFRIGERATED. ONE WAS A FEW WEEKS AGO AND THAT WAS A 500ML NS BAG. TODAY IT HAPPENED ON A NS 250ML BAG (NDC 338-0049-02, LOT Y33271 EXP 8/21). I¿M NOT SURE WHAT LOT/ETC THE C100 WAS FROM AS THE PACKAGING WAS PREVIOUSLY DISPOSED OF IN ANOTHER ROOM. ADDITIONAL INFO: CURRENTLY WE HAVE THE FOLLOWING IN OUR COMPOUNDING ROOM: OPTIMA COMPONENTS C100-O BULK C100 LOT 1910102 EXP 09-30-2020 REFERENCE 515079 THIS COMPLAINT CAPTURES THE EVENT THAT OCCURRED ON 14-APR AND THE OCCURRENCE IN THE PAST ON AN UNKNOWN DATE. ADDITIONAL INFORMATION: BOTH OF MY EXAMPLES OCCURRED WITHIN THE PHARMACY MIXING AREA. IN ONE INSTANCE THE MEDICATION WAS BEING MIXED INSIDE THE HAZARDOUS HOOD. THE TECHNICIAN WAS ADDING CISPLATIN TO THE IV BA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10027224 ↗