BD PhaSeal Optima 515078Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00382905150784), received between Aug 23, 2023 and Sep 22, 2026 — classified as 41 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (13 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. How this data works · Data updated Oct 13, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860028 ↗
• MalfunctionSep 21, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50849046 ↗
• MalfunctionApr 17, 2026Infusion or Flow Problem

  IT WAS REPORTED THAT THE BD INFUSION ADAPTER C100-O HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT, CONNECTED THE NEW ANTIBIOTIC INFUSION SYSTEM. WHEN A COLLEAGUE ENTERED THE PATIENT¿S ROOM, ANTIBIOTIC SOLUTION WAS STILL PRESENT IN THE CONTAINER, BUT THE DRIP CHAMBER OF THE INFUSION SET WAS EMPTY AND THERE WAS AIR IN THE TUBING. THE CONNECTION BETWEEN THE ANTIBIOTIC AND THE INFUSION SET WAS QUICKLY DISCONNECTED, THE AIR WAS FLUSHED OUT, AND THE ANTIBIOTIC WAS THEN CONNECTED DIRECTLY TO THE INFUSION SET WITHOUT THE INTERMEDIATE CONNECTOR. THIS FUNCTIONED CORRECTLY. FORTUNATELY, ANTIBIOTIC SOLUTION WAS STILL PRESENT IN THE TUBING AND NO AIR HAD REACHED THE PATIENT. AIR DETECTED IN INFUSION TUBING DURING ANTIBIOTIC ADMINISTRATION WHEN DID THE INCIDENT OCCUR? DURING USE NO MORE INFORMATION FROM CUSTOMER, DESPITE MULTIPLE EMAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24918258 ↗
• MalfunctionMar 31, 2026Air/Gas in Device

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741645 ↗
• MalfunctionMar 5, 2026Connection Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24527021 ↗
• MalfunctionMar 5, 2026Connection Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24527019 ↗
• MalfunctionMar 5, 2026Connection Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24527015 ↗
• MalfunctionFeb 25, 2026Connection Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24449400 ↗
• MalfunctionFeb 25, 2026Connection Problem

  IT WAS REPORTED THAT THE BD INFUSION ADAPTER C100-O SPIKE CAME OUT OF THE BAG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 515078, BATCH # 2502506. IT WAS REPORTED BY CUSTOMER THAT THE PHASEAL ADAPTER SPIKE HAS BEEN DISLODGING FROM IV BAG FOR NO APPARENT REASON. APPEARS TO BE VERY LOOSE AT IV BAG INSERTION IF THE SPIKE HAS BEEN TWISTED AFTER INSERTION. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PRODUCT CODE: 515078. PRODUCT DESCRIPTION: ADAPTER INFUSION C100-O CA/4 X 40S. LOT/SERIAL #: (B)(6). EXPIRY DATE: 2027-01-31. PROBLEM INFORMATION: PRODUCT CONCERN TICKET NUMBER: (B)(4), DATE OF INCIDENT: (B)(6) 2026, CONCERN DESCRIPTION: PHASEAL ADAPTER SPIKE HAS BEEN DISLODGING FROM IV BAG FOR NO APPARENT REASON. APPEARS TO BE VERY LOOSE AT IV BAG INSERTION IF THE SPIKE HAS BEEN TWISTED AFTER INSERTION. OCCURRENCES: 1 EACH. ADDITIONAL INFORMATION RECEIVED ON 18-FEB-2026: WITH THE CSTD SPIKE DISLODGING FROM THE BLINA IV BAG DURING IV INFUSION, THERE WAS A RISK OF INFECTION AND AIR EMBOLISM, AS THE TUBING AND SPIKE WERE OPEN TO AIR DURING INFUSION FOR AN EXTENDED PERIOD OF TIME ¿ IV TUBING WAS CONNECTED TO CENTRAL LINE. THERE HAVE BEEN (B)(

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24449389 ↗
• MalfunctionFeb 4, 2026Connection Problem

  IT WAS REPORTED THAT THE BD INFUSION ADAPTER C100-O HAD A LOOSE CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER USES A B. BRAUN 1000ML SALINE BAG FOR ETOPOSIDE DOSES (OCCUR WEEKLY-BIWEEKLY). BD'S OPTIMA INFUSION ADAPTER C100-O DOES NOT SEAT SECURELY INTO THE PORT OF THIS SPECIFIC 1000ML SALINE BAG CURRENTLY IN USE. THE COLLAR OF THE SPIKE DOES NOT FIT INTO THE PORT, CAUSING IT TO BE EASILY PULLED OUT. THIS CREATED SOME CONCERN FROM THE PHARMACISTS. NO IMPACT TO PATIENT. PLEASE PROVIDE INVESTIGATION RESPONSE TO ME AT (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24264493 ↗
• MalfunctionNov 10, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512628 ↗
• MalfunctionOct 29, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  EVENT DETAILS: CUSTOMER IS SPIKING BAGS WITH THE OPTIMA INFUSION ADAPTOR (C100-O) AND HAS SEEN A PLASTIC PARTICLE FROM THE ENTRY POINT GO UP INTO THE BAG. THIS HAS HAPPENED WITH BOTH AN EMPTY BAG AND A 250 ML SALINE BAG MIXED WITH A HAZARDOUS DRUG. CUSTOMER IS CONCERNED ABOUT THE SMALL PLASTIC PIECE ENTERING THE BAG. PER CUSTOMER RESPONSE 24OCT2025: THE FLOATING PLASTIC PIECE APPEARS LIKE A CLEAR AIR BUBBLE, IT WAS FOUND ON PHYSICAL INSPECTION OF A CHEMO BAG. HOWEVER, YOU CAN TELL IT¿S ACTUALLY PLASTIC BECAUSE IT CAN¿T BE DISPERSED AND IS HARD WHEN YOU PRESS DOWN ON IT. THIS OCCURRED WITH BOTH OF THESE PRODUCTS AT OUR SYSTEM: ¿ (B)(4) OF BAXTER INTRAVIA CONTAINER, EMPTY. 150ML CAPACITY. ¿ BBRAUN 250ML NS, LOT J5D844, EXP 03/2027.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23413354 ↗
• MalfunctionOct 20, 2025Leak/Splash; Nonstandard Device; Defective Component; Leak/Splash; Nonstandard Device; Defective Component

  EVENT DETAILS: SPILLS OCCURRED AFTER IV BAGS PREPARED WITH IRINOTECAN WERE STORED IN THE FRIDGE. THE SECOND SPILL OCCURRED OVERNIGHT WHILE THE BAG WAS IN THE FRIDGE. IT LEAKED FROM THE INFUSION ADAPTER AND THROUGH TWO ZIPLOC BAGS. BOTH INCIDENTS HAPPENED AT TWO DIFFERENT LOCATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336861 ↗
• MalfunctionOct 20, 2025Break; Fluid/Blood Leak; Defective Component; Break; Fluid/Blood Leak; Defective Component

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336575 ↗
• MalfunctionSep 2, 2025Disconnection; Disconnection

  IT IS REPORTED DISCONNECTION. EVENT DESCRIPTION: A CHEMOTHERAPY LEAK WAS REPORTED FROM A FRESENIUS FLUID BAG WITH BD SECONDARY TUBING AND PHASEAL CSTD. THE CHEMO WAS LEAKING FROM THE SPIKE IN THE BAG AS WELL AS THE CSTD HAD MALFUNCTIONED AND DISCONNECTED FROM THE END OF THE TUBING. MEDICATION HAD LEAKED INTO THE HAZ BAG (ALL CHEMO'S ARE DOUBLE BAGGED WITH HAZARDOUS CHEMO BAGS). NURSING CAUGHT THIS BEFORE EXPOSURE COULD HAPPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22938013 ↗
• MalfunctionSep 2, 2025Leak/Splash; Leak/Splash

  IT IS REPORTED LEAKAGE. EVENT DESCRIPTION: A CHEMOTHERAPY LEAK WAS REPORTED FROM A FRESENIUS FLUID BAG WITH BD SECONDARY TUBING AND PHASEAL CSTD. THE CHEMO WAS LEAKING FROM THE SPIKE IN THE BAG AS WELL AS THE CSTD HAD MALFUNCTIONED AND DISCONNECTED FROM THE END OF THE TUBING. MEDICATION HAD LEAKED INTO THE HAZ BAG (ALL CHEMO'S ARE DOUBLE BAGGED WITH HAZARDOUS CHEMO BAGS). NURSING CAUGHT THIS BEFORE EXPOSURE COULD HAPPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22937549 ↗
• MalfunctionJul 28, 2025Contamination; Contamination

  DESCRIPTION: IT WAS REPORTED BY CUSTOMER PRECIPITANT IN THE BAG. EVENT DETAILS: TODAY WE HAVE HAD SEVERAL ISSUES WITH PRECIPITANTS AND PLASTICS IN THE BAGS. WE HAD A TOTAL OF THREE 200 MG KEYTRUDA BAGS ($10,000 A PIECE), ONE 1500 MG IMFINZI BAG ($13,000) AND TWO 420 MG PERJETA BAGS ($ 4,000 A PIECE). WE ALSO HAD 2 KEYTRUDA VIALS ($10,000) THAT HAVE PRECIPITANT AFTER THE VIAL WAS SPIKED WITH VIAL ADAPTERS (LOT#2410402). HOWEVER, WHEN WE TROUBLESHOT THE COMPOUNDING OF ONE OF OUR KETRUDA BAGS,  WE INJECTED KEYTRUDA ONLY WITH NEEDLES AND SPIKED THE SECONDARY SET, BUT WE STILL HAD PRECIPITATION IN THE BAG. THE BAG SPIKE LOT # 2405504. WE'RE JUST GRASPING AT STRAWS TO FIGURE OUT WHY THIS OCCURRED.  ADDITIONAL INFORMATION: IT IS VERY DIFFICULT TO SEE BUT IT LOOKS LIKE MICROPARTICLES SUSPENDED IN SOLUTION. COULD BE DRUG OR AIR BUBBLES, BUT I WANT IT TESTED TO BE SAFE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628976 ↗
• MalfunctionJul 7, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DESCRIPTION: IT IS REPORTED, FOREIGN MATTER. EVENT DETAILS: WE HAVE NOTICED SOME SMALL PARTICULATES IN BAGS AFTER COMPOUNDING THAT LOOKS LIKE SMALL STRANDS OF CLEAR PLASTIC. AT FIRST, I THOUGHT IT WAS ISOLATED TO 2 BAGS OF NS 100 ML WITH KEYTRUDA, BUT WE FOUND ANOTHER PIECE IN A TRAZIMERA BAG IN NS 250 ML. WE HAVE ALSO HAD ISSUES WITH THE SPIKE ADAPTER CORING OUR TRAZIMERA VIALS. PLEASE CONFIRM WHEN THE PLASTICS WERE IDENTIFIED: ON VERIFICATION OF THE FINAL PRODUCT. THE BAGS WERE BOTH SPIKED WITH THE BD PHASEAL OPTIMA INFUSION ADAPTER (515078). ADDITIONAL INFORMATION: WHAT WERE THE DATES OF EVENTS? 6/24/2025. PLEASE CONFIRM WHEN THE PLASTICS WERE IDENTIFIED. (BEFORE OR DURING ADMINISTRATION). ON VERIFICATION OF THE FINAL PRODUCT. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. WE HAD TO REMAKE THE IV FOR THE PATIENT. PLEASE DESCRIBE WHERE YOU BELIEVE THE MICROPLASTICS TO BE ORIGINATING FROM. WE THINK THE PLASTIC MAY BE COMING FROM THE SECONDARY SET DUE TO THE PLASTICS BEING IN TWO 100ML BAGS AND A 250ML BAG. BOTH BAG SIZES HAD DIFFERENT DRUGS IN THEM AS WELL. PLEASE DETAIL THE SIZE OF THE VIAL NECK OF THE IMPACTED VIALS (1

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412561 ↗
• MalfunctionMay 15, 2025Break; Break

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22029816 ↗
• MalfunctionApr 29, 2025Connection Problem; Connection Problem

  NO ADDITIONAL INFORMATION

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925605 ↗
• MalfunctionApr 17, 2025Leak/Splash; Leak/Splash

  THE FOLLOWING WAS OPENED IN RELATION TO (B)(6) BASED ON ADDITIONAL PRODUCTS RECEIVED. IT WAS REPORTED BY REP: THE ACCOUNT HAD NOTED THAT THEY WERE EXPERIENCING THE RESIDUAL DRUG ON ALL THREE COMPONENTS: P-13, C-100, P-20. SINCE I HAVE BEEN IN THE ACCOUNT, THEY HAVE NOT EXPERIENCED THIS SPECIFIC ISSUE AGAIN. THE PRODUCTS THAT WERE RETURNED WERE UNUSED BUT IN THE SAME LOT AS THE ONES THAT EXPERIENCED THESE ISSUES. NO USER OR PATIENT IMPACT. YES, MY CLINICAL SPECIALIST AND I WENT IN AND PROVIDED ADDITIONAL EDUCATION TO THE TEAM AND THEY FEEL CONFIDENT WITH ALL COMPONENTS NOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860429 ↗
• MalfunctionFeb 24, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21445512 ↗
• MalfunctionDec 30, 2024Material Separation; Material Separation

  MATERIAL # 515078. BATCH # 2404502. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. BLUE PIECE CAME DETACHED CAUSING CHEMO SPILL. WE HAD AN RN IN OUR XXX CALL TODAY TO REPORT THEY JUST HAD A CHEMO SPILL CAUSED BY THE C100 BAG SPIKE COMING COMPLETELY OUT OF THE BAG. WE THOUGHT IT STRANGE AS THE SPIKE IS PUSHED FIRMLY INTO THE PORT END HOWEVER WHEN THE PRODUCT (WHICH HAPPENED TO BE A VERY EXPENSIVE MEDICATION) WAS REMADE AND BROUGHT UP TO THE UNIT THE RN EXPLAINED TO THE TECHNICIAN WHAT HAD HAPPENED. SHE POPPED THE BOTTOM END OF THE LINE ACCESS COVER ON THE BOTTOM OF THE C100 SPIKE AND THE WHOLE BLUE RUBBER PART OF THE C100 PHASEAL CAME OFF FROM THE WHITE HARD PLASTIC PIECE. I ATTEMPTED TO PULL DOWN ON THE BLUE RUBBER PART OF A NEW C100 AND WITH SOME TRYING, IT DID COME APART. I DON'T KNOW IF THEY HAD A FAULTY C100 OR IF SOME OTHER THING HAPPENED. WE WANTED TO PUT THIS OUT THERE IN CASE THERE ARE OTHERS WHO EXPERIENCE AN ISSUE. THE BATCH THIS WAS FROM IS LOT 2404502. PRODUCT CODE: 2404502. CUSTOMER RESPONSE ON DECEMBER 23, 2024. 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT MM-DD-YYYY? 12-17-2024. 2. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21035990 ↗
• MalfunctionDec 3, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20836310 ↗
• MalfunctionNov 27, 2024Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION: 04DEC2024: BATCH NUMBER PROVIDED 2407502.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20799793 ↗