BD PhaSeal 515056Recalls & reported problems

Summary

The FDA's MAUDE database contains 159 adverse event reports that list this exact device (DI 00382905150562), received between May 18, 2021 and Sep 18, 2026 — classified as 159 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (84 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 159 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831238 ↗
• MalfunctionSep 18, 2026Leak/Splash; Use of Device Problem

  No additional information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50830718 ↗
• MalfunctionSep 16, 2026Disconnection

  Patient problems: Chemical Exposure

  MAUDE report 50796944 ↗
• MalfunctionSep 16, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50787127 ↗
• MalfunctionSep 9, 2026Disconnection; Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50691136 ↗
• MalfunctionAug 25, 2026Infusion or Flow Problem

  The following information was provided by the initial reporter:Material # Unknown. Batch # Unknown.It was reported by customer that "Kink in line above the filter, one way valve on the drip chamber back flowed backwards down to the filter when connected via optima pieces, Does not allow flow of the line as they do circle priming of the sets".Verbatim:10015861A,20350E, plus optima piece.Kink in line above the filter. one way valve on the drip chamber back flowed backwards down to the filter when connected via optima pieces in a circle prime fashion when the valve on the drip chamber should be one way only up into the bag.Multiple overall complaints of kinking from this facility. Does not allow flow of the line as they do circle priming of the sets. They are having to discard the set in most cases and grab new that are not kinked.No patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50429194 ↗
• MalfunctionAug 16, 2026Disconnection

  The following information was provided by the initial reporter:Material #:515056 Batch#: Unknown.It was reported by a customer that they experienced 22 disconnections of the phaseal optima N40 O locking injector to the alaris tubing set spin collars. Verbatim:has experienced 22 disconnects of the Phaseal Optima N40 O locking injector to the Alaris tubing set spin collars. These have led to delays in customer care and spills. Despite training and resources, this has been an ongoing challenge at.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50267868 ↗
• MalfunctionAug 16, 2026Disconnection

  The following information was provided by the initial reporter:Material # :515056 Batch#: Unknown.It was reported by a customer that they experienced 22 disconnections of the phaseal optima N40-O locking injector to the alaris tubing set spin collars. Verbatim:has experienced 22 disconnects of the Phaseal Optima N40 O locking injector to the Alaris tubing set spin collars. These have led to delays in customer care and spills. Despite training and resources, this has been an ongoing challenge at.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50263795 ↗
• MalfunctionApr 3, 2026Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24783120 ↗
• MalfunctionFeb 20, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD INJECTOR LOCKING N40-O HAD LEAKAGE THROUGH THE MEMBRANE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 515056 BATCH # UNKNOWN. VERBATIM: 2/1 DOSE OF METHOTREXATE HAD LEAKED OUT THE END OF THE PHASEAL (WHICH SHOULD NOT BE ABLE TO HAPPEN--IT IS SUPPOSED TO BE A CLOSED SYSTEM AND WAS NOT ATTACHED TO THE OTHER PART OF THE PHASEAL WHICH ALLOWS FLOW). THERE WAS SUPPOSED TO BE SOMETHING LIKE 0.32ML IN THE SYRINGE BUT THERE WAS ONLY 0.3 AND WE COULD SEE THE YELLOW CHEMO UNDER THE CLEAR CAP OF THE PHASEAL. CHEMO PHARMACY THANKFULLY MADE US A NEW DOSE AND WE TOOK A PICTURE OF THE LEAKED DOSE HAZARDOUS DRUG EXPOSURE, DELAY IN CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401043 ↗
• MalfunctionFeb 4, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD INJECTOR LOCKING N40-O HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #515056; LOT #UNKNOWN. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. LEAKING FROM AROUND THE RING. I WAS ABLE TO SPEAK TO THE TWO RNS WHO WERE PRESENT. THEY STATED THAT IT WAS LEAKING FROM AROUND THE RING/SEAL OF THE INJECTOR THAT WAS ON THE IV LINE. SO THAT WOULD HAVE BEEN THE PRIMARY LINE THAT THE RNS PLACE THE PHASEAL, BUT THEY WERE ADAMANT THAT IT WAS NOT LEAKING FROM AROUND THE SCREW CONNECTION, THAT IT WAS LEAKING FROM THE RING AROUND THE EDGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24264178 ↗
• MalfunctionFeb 3, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD INJECTOR LOCKING N40-O HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DOXORUBICIN PUSH MEDICATION LEAKING WHEN BEING ADMINISTERED THROUGH PHASEAL OPTIMA. CAUSING DRUG LOSS AND HAZARDOUS DRUG EXPOSURE. PHASEAL OPTIMA INJECTOR FOR CHEMOTHERAPY PUSH OF DOXORUBICIN NOT STOPPING THE FLOW OF CHEMOTHERAPY FROM THE SYRINGE IT WAS CONTAINED IN. DOXORUBICIN LEAKING AND DRIPPING AT THE END OF THE DEVICE UPON ARRIVAL TO 4 ONC. THE LEAKING CHEMOTHERAPY ALSO MADE THE PHASEAL OPTIMA CONNECTOR POP LOOSE DURING THE PUSH AND REQUIRED THE CONNECTOR BEING HELD IN AND CONSTANTLY PUSHED BACK IN AS WELL AS CHEMOTHERAPY OOZING OUT THE SIDE AT TIMES. RN (B)(6) REPORTS THIS IS THE SECOND TIME SHE HAS SEEN THIS RECENTLY. PER REP RESPONSE ON 22DEC2025: I HAVE REQUESTED LOT NUMBER INFORMATION BUT DO NOT HAVE THAT INFORMATION YET. THE IMPACT TO PATIENT WOULD BE DELAY IN CARE, AMOUNT OF DRUG RECEIVED, AND HAZARDOUS DRUG EXPOSURE TO PATIENT AND STAFF. PER REP RESPONSE: WAS THE LEAKAGE NOTED WHILE PERFORMING THE PUSH OF MEDICATION OR DID IT ARRIVE TO THE PATIENT ROOM WITH EVIDENCE OF LEAKAGE? LEAKAGE WAS NOTED WHEN IT ARRIVED TO THE NURSING UNIT. CAN YOU PR

  Patient problems: Insufficient Information

  MAUDE report 24254464 ↗
• MalfunctionJan 16, 2026Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: Chemical Exposure

  MAUDE report 24095728 ↗
• MalfunctionJan 8, 2026Leak/Splash

  ADDITIONAL INFORMATION: DCHU MET WITH REPS TO CLARIFY EVENT DETAILS AS EMAIL RESPONSES WERE CONFLICTING TO WHAT WAS REPORTED. BASED ON PROVIDED INFORMATION, THERE WAS A LEAKAGE AT THE LUER CONNECTION OF THE CONNECTOR AND MATING TUBING. MATING TUBING DOES NOT BELONG TO BD. THERE WAS NO CLEAR EVIDENCE OF A DISCONNECTION AT THE TIME OF THE INCIDENT, HOWEVER, UPON REVIEWING THE EVENT DETAILS WITH THE CUSTOMER, IT IS BELIEVED THEY WERE NOT USING THE PROPER TECHNIQUES WHEN CONNECTING THE DEVICES. REPS WENT ON SITE AND PERFORMED ADDITIONAL TRAINING TO ENSURE THEY ARE FULLING CONNECTING THE DEVICES. THERE WAS NOT IMPACT TO THE PATIENT OR HEALTHCARE PROFESSIONAL. THERE IS ONLY ONE CONNECTOR LOT AT THIS FACILITY, 2508501. NO SAMPLES AVAILABLE AT THIS TIME.

  Patient problems: Chemical Exposure

  MAUDE report 24007894 ↗
• MalfunctionJan 8, 2026Leak/Splash

  EVENT DETAILS: DURING INFUSION OF HIGH-DOSE MELPHALAN, A MINOR LEAK OCCURS IN THE CONNECTION BETWEEN THE DRIP TUBE AND CONNECTOR. THE PATIENT RECEIVES AN ESTIMATED ONE MILLILITER OF CHEMOTHERAPY ON THE RIGHT UPPER ARM AND ONE MILLILITER ON THE SHEET. THE DRIP IS STOPPED. THE SKIN IS WASHED ABUNDANTLY WITH SOAP AND WATER AND THE SHEETS ARE CHANGED. AFTER SWITCHING WITH A NEW CONNECTOR, MELPHALANET CAN BE RESTARTED WITHOUT REMARK NO OBVIOUS IRRITATION IS NOTED ON THE SKIN.

  Patient problems: Chemical Exposure

  MAUDE report 24007877 ↗
• MalfunctionJan 8, 2026Leak/Splash

  EVENT DETAILS: DURING INFUSION OF HIGH-DOSE MELPHALAN, A MINOR LEAK OCCURS IN THE CONNECTION BETWEEN THE DRIP TUBE AND CONNECTOR. THE PATIENT RECEIVES AN ESTIMATED ONE MILLILITER OF CHEMOTHERAPY ON THE RIGHT UPPER ARM AND ONE MILLILITER ON THE SHEET. THE DRIP IS STOPPED. THE SKIN IS WASHED ABUNDANTLY WITH SOAP AND WATER AND THE SHEETS ARE CHANGED. AFTER SWITCHING WITH A NEW CONNECTOR, MELPHALANET CAN BE RESTARTED WITHOUT REMARK NO OBVIOUS IRRITATION IS NOTED ON THE SKIN

  Patient problems: Chemical Exposure

  MAUDE report 24007875 ↗
• MalfunctionJan 6, 2026Disconnection; Leak/Splash

  ADDITIONAL INFORMATION FROM CUSTOMER JAN 12TH: THE NURSE NOTICED THE LEAK IMMEDIATELY, AS THIS WAS A VERY SMALL THAT HAD LEAKED OUT. THE NURSE IMMEDIATELY PAUSED THE ALARIS PUMP AND REPLACED THE INJECTOR ON THE PATIENT INFUSION LINE. NO MEDICAL INTERVENTION WAS DONE DUE TO UNNECESSARY EXPOSURE TO HAZARDOUS DRUG, FROM PATIENT OR NURSE PERSPECTIVE.

  Patient problems: Chemical Exposure

  MAUDE report 23985535 ↗
• MalfunctionJan 6, 2026Disconnection; Leak/Splash

  EVENT DETAILS: CUSTOMER REPORTED THE LOCKING INJECTOR N-40 (515056) COMES OFF THE END OF THE TUBING. IT HAS RESULTED IN (MINOR) CHEMO SPILLS. ANY REPORTS OF THIS ISSUE WITH THE AFFECTED LOT OF: 2410303. WE HAVE PROVIDED RE-EDUCATION TO STAFF TO ENSURE A TIGHT FIT (INSERT AND TWIST) BETWEEN THE LOCKING INJECTOR AND THE TUBING. THAT SAID, I CANNOT 100% RULE OUT USER ERROR. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. BOTH EVENTS ENDED WITH A CHEMO SPILL AND UNNECESSARY EXPOSURE OF HAZARDOUS DRUG. HAVE YOU CONFIRMED THAT THE CONNECTIONS WERE PROPERLY SECURED? ASSOCIATE DIRECTOR (AD) OF ONCOLOGY PHARMACY CANNOT 100% VALIDATE. AD WAS ABLE TO SPEAK WITH TECHNICIAN COMPOUNDING WHO CONFIRMED THAT SHE DID HAVE A TIGHT CONNECTION AND HAS NOT HAD ISSUES WITH OVER THE PREVIOUS SIX MONTHS SINCE BEGINNING COMPOUNDING WITH CSTD. HAVE YOU SECURED THE INJECTOR AND CONNECTOR WITH M25 INFUSION CLAMP? NO WAS THERE ANY DEFORMITIES? UNAWARE, IF THERE WERE ANY WHAT KIND OF CHEMO DRUG WAS USED? DOCETAXEL HAVE YOU REPLACED THE DEFECTIVE INJECTOR AND SUCCESSFULLY COMPLETED THE MEDICATION PROCEDURE? YES.

  Patient problems: Chemical Exposure

  MAUDE report 23985533 ↗
• MalfunctionDec 2, 2025Disconnection; Leak/Splash; Disconnection; Leak/Splash

  ADDITIONAL INFORMATION: THE CONNECTOR DISCONNECTED FROM THE MATING TUBING. MATING TUBING DOES NOT BELONG TO BD. BD SALES REP WENT TO FACILITY AND MET WITH CUSTOMER TO REVIEW PROCESS, IT IS BELIEVED THEY WERE NOT USING THE PROPER TECHNIQUES WHEN CONNECTING THE DEVICES. REPS COMPLETED ADDITIONAL TRAINING TO ENSURE THEY ARE FULLING CONNECTING THE DEVICES. THERE WAS NOT IMPACT TO THE PATIENT OR HEALTHCARE PROFESSIONAL. THERE IS ONLY ONE CONNECTOR LOT AT THIS FACILITY, 2508501. NO SAMPLES AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23698355 ↗
• MalfunctionDec 2, 2025Leak/Splash; Leak/Splash

  EVENT DETAILS: I WAS ADMINISTERING AZACITIDINE SC TO A PATIENT. UPON ADMINISTERING THE FIRST SYRINGE, A FEW DROPS OF THE AZACITIDINE LEAKED OUT OF THE END OF THE CSTD CLOSEST TO THE PATIENT (WHERE THE MALE AND FEMALE PIECE CONNECT). A FEW DROPS OF AZACITIDINE SPILLED ONTO THE PATIENT, THE REST OF THE DOSE WAS ADMINISTERED. A CLICK WAS HEARD WHEN I WAS CONNECTING ALL MALE AND FEMALE CSTD PIECES AND THEY LOOKED SECURE UPON ADMINISTRATION. THE SPILL WAS CLEANSED WITH GAUZE AND ALCOHOL SWABS AND THE PATIENT WAS MADE AWARE TO DOUBLE WASH HIS PANTS IMMEDIATELY UPON RETURNING HOME.". COMPLAINT NOTICED: DURING / AFTER USE. PROBLEM FREQUENCY: 1ST TIME. PATIENT INJURY: NO. QTY AFFECTED: 1 EACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694423 ↗
• MalfunctionSep 2, 2025Leak/Splash; Separation Problem; Leak/Splash; Separation Problem

  ADDITIONAL INFORMATION I KNOW OF 3 OCCURRENCES OVER THE PAST SEVERAL WEEKS SWIVEL ATTACHMENT IS DETACHING FROM LINE. WHAT KIND OF CHEMO DRUG WAS USED? 5 FLUOROURACIL 5ML PER HR, NO ERRORS PRIOR TO DISCONNECTION HAVE YOU REPLACED THE DEFECTIVE PRODUCT AND SUCCESSFULLY COMPLETED THE MEDICATION PROCEDURE? YES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22947918 ↗
• MalfunctionAug 13, 2025Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION: NO VISIBLE DAMAGE BUT LEAK APPEARED TO BE COMING FROM THE SPIN COLLAR ALARIS INFUSION PUMP; CYTARABINE PF AT 46 ML/HR INFUSION RETURNED TO PHARMACY AND ANOTHER CSTD INJECTOR WAS PLACED ON THE IV TUBING EVENT OCCURRED 08-05-2025. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22800711 ↗
• MalfunctionAug 11, 2025Disconnection; Disconnection

  IT IS REPORTED CONNECTION ISSUES. EVENT DESCRIPTION: OPTIMA N-40 INJECTOR SEPARATED FROM PRIMARY LINE AT LUER CONNECTION RESULTING IN CHEMO SPILL. FAILURE AT PRIMARY LINE CONNECTION TO PATIENT ACCESS POINT. OCCURS WITH 24 HR INFUSIONS. INFUSION CLAMP IS BEING USED. 8 SEPARATE INCIDENCES OCCURRED FROM APRIL 2024 TO PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22772210 ↗
• MalfunctionAug 11, 2025Disconnection; Disconnection

  IT IS REPORTED CONNECTION ISSUES. EVENT DESCRIPTION: OPTIMA N-40 INJECTOR SEPARATED FROM PRIMARY LINE AT LUER CONNECTION RESULTING IN CHEMO SPILL. FAILURE AT PRIMARY LINE CONNECTION TO PATIENT ACCESS POINT. OCCURS WITH 24 HR INFUSIONS. INFUSION CLAMP IS BEING USED. (B)(4) SEPARATE INCIDENCES OCCURRED FROM (B)(6) 2024 TO PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22772206 ↗
• MalfunctionJul 28, 2025Disconnection; Disconnection

  IT IS REPORTED, DISCONNECTION. EVENT DESCRIPTION: I WAS USING THE NEW PHASEAL OPTIMA YESTERDAY WHEN I WAS EXPOSED TO CYTOTOXIC MEDICATION. I WAS TRYING TO ADD MORE AIR TO THE EXPANDING CHAMBER ON THE PROTECTOR AS I WAS USING THE SAME VIAL FOR A SECOND PATIENT AND DID NOT HAVE ENOUGH AIR IN THE CHAMBER TO WITHDRAW THE AMOUNT OF DRUG NEEDED. IN THE PAST, WE WOULD APPLY A LITTLE PRESSURE WITH THE SYRINGE/INJECTOR AND HOLD AND THE EXPANDING CHAMBER WOULD THEN EVENTUALLY EXPAND. YESTERDAY, INSTEAD OF THAT HAPPENING, THE SYRINGE DISCONNECTED FROM THE INJECTOR AND DRUG STARTED ERUPTING FROM THE INJECTOR STILL ATTACHED TO THE PROTECTOR. DRUG WENT ON MY GOWN, ON MY PROTECTIVE WINDOW, AND ON MY WORKSTATION. THIS HAS NEVER HAPPENED USING OUR OLD PHASEAL PRODUCTS. PER CUSTOMER RESPONSE: THESE WHERE THE PRODUCTS I WAS USING AND THE DRUG WAS PACLITAXEL. SEVERITY LEVEL 1-NO HARM/DAMAGE. NOT THE ORIGINAL, BUT THEY CAME FROM THE SAME BOX. NOT SURE IF THAT WILL HELP, BUT THE PRODUCTS IN QUESTION WERE THROWN OUT AFTER USE SINCE THEY WERE DEFECTIVE AND HAD BEEN IN CONTACT WITH CYTOTOXIC MEDICATION.

  Patient problems: Chemical Exposure

  MAUDE report 22629027 ↗