BD PhaSeal 515100Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00382905151002), received between Jan 9, 2018 and Oct 29, 2025 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (18 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2025Leak/Splash; Leak/Splash

  EVENT DETAILS: I AM HOPING YOU CAN POINT ME IN THE RIGHT DIRECTION OF WHO TO SPEAK WITH REGARDING A CONCERN WITH OUR PHASEAL PIECES. I HAVE BEEN USING PHASEAL FOR OVER 10 YEARS TO ADMINISTER CHEMOTHERAPY, RECENTLY I HAVE HAD TWO BOTTLES OF VINCRISTINE LEAK SIGNIFICANTLY AT THE POINT WHERE THE PROTECTOR P14 IS ATTACHED. I DID INSPECT THE BOTTLE TO ENSURE THE P14 WAS APPLIED CORRECTLY AND "SNAPPED IN" TO THE LID, WHICH IT WAS. SINCE THIS IS THE SECOND TIME THIS HAS HAPPENED, I WANTED TO REACH OUT TO SEE IF THIS WAS A KNOWN PROBLEM OR IF YOU HAVE ANY SUGGESTIONS ON HOW TO AVOID THIS IN THE FUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23413360 ↗
• MalfunctionJun 23, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED LEAKAGE OCCURRED. EVENT DETAILS: DURING RECONSTITUTION OF METHOTREXATE USED FOR ECTOPIC PREGNANCY WITH THE BD PHASEAL¿ SYSTEM KIT PART NUMBERS 515003 (INJECTOR®), 515100 (PROTECTOR®), AND BATCHES 2408005 (INJECTOR®) AND 2406113 (PROTECTOR®); A LEAKAGE OF THE PRODUCT IS OBSERVED. IN FACT, THE NURSE CONNECTS THE SYRINGE TO THE KIT AND INJECTS AIR INTO THE BOTTLE IN ACCORDANCE WITH THE MANUFACTURER'S RECOMMENDATIONS. AS SHE DREW IN THE CONTENTS WITH THE SYRINGE, A LEAKAGE OF PRODUCT WAS OBSERVED BETWEEN THE INJECTOR® AND THE PROTECTOR®, AND THE PRODUCT DRIPPED ONTO THE NURSE'S OPEN FIELD AND GLOVES. THE ENTIRE BOTTLE LEAKED. THE NURSE USED ANOTHER KIT WITH THE SAME REFERENCES AND UNKNOWN BATCHES, TO SUCCESSFULLY ADMINISTER THE PRESCRIBED DOSAGE OF METHOTREXATE. NUMBER OF PATIENTS OR PERSONS CONCERNED: 1. NUMBER OF DEVICES INVOLVED: 1. CLINICAL CONSEQUENCES AND CURRENT STATUS OF PATIENT OR PERSON INVOLVED: EXPOSURE OF NURSING STAFF TO A HAZARDOUS SUBSTANCE AS A RESULT OF METHOTREXATE SPILLAGE (BUT NO DIRECT CONTACT WITH ORAL OR OCULAR SKIN OR MUCOUS MEMBRANES). NO CLINICAL CONSEQUENCES FOR THE PATIENT. TIME LOST: 10 MINUTES WHILE ANOTHER KIT IS USED.

  Patient problems: Chemical Exposure

  MAUDE report 22307649 ↗
• MalfunctionJun 9, 2025Material Separation; Material Separation

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22168803 ↗
• MalfunctionJun 6, 2025Leak/Splash; Leak/Splash

  VERBATIM: SAME ISSUE HAPPENED ON SECOND TIME WHICH IS ON (B)(6) 2025 - THE PRODUCT IS THE PHASEAL PROTECTOR P14. REF NUMBER 515100. LOT NO 2406113. - I'M WRITING TO FOLLOW UP ON OUR PREVIOUS INVESTIGATION INTO LEAKING MITOXANTRONE BOTTLES WHEN USED WITH THE PHASEAL SYSTEM. WE DID NOT INITIALLY KEEP THE BOTTLE PHASEAL SET TO SEND YOU FOR EXAMINATION, HOWEVER WE HAVE SINCE USED THIS DRUG AGAIN AND HAD THE SAME ISSUE MEANING THIS IS THE THIRD TIME, BUT THIS TIME WE RETAINED THE BOTTLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22158551 ↗
• MalfunctionMar 30, 2025Leak/Splash; Leak/Splash

  THE FOLLOWING WAS REPORTED: WE HAVE A LEAKING ISSUE WITH OUR P14 VIAL ADAPTORS WITH THE LOT NUMBER #2404123. WE HAVE 36 UNUSED ADAPTORS REMAINING IN THE BOX. WE WERE TOLD BY OUR DISTRIBUTOR THAT Y'ALL PREFER TO HANDLE THESE ISSUES DIRECTLY WITH US RATHER THAN THEM. I CALLED LAST WEEK BUT I HAVEN'T HEARD BACK YET. IF SOMEONE CAN CALL SO THAT WE CAN DISCUSS THE ISSUE AND WHAT TO DO MOVING FORWARD, THAT WOULD BE GREAT. PER FOLLOW UP FROM CUSTOMER 14MAR2025: 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 21 FEB 2025 (2 ADAPTORS), 25 FEB 2025 (1 ADAPTOR), 26 FEB 2025 (3 ADAPTORS), 28 FEB 2025 (1 ADAPTOR). LOT # 2404123. ADDITIONAL INFORMATION: YES, THE LEAK IS BETWEEN THE ADAPTER AND THE VIAL. IT WAS ATTACHED USING THE ASSEMBLY FIXTURE. NO ONE WAS HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21728719 ↗
• MalfunctionMar 30, 2025Leak/Splash; Leak/Splash

  THE FOLLOWING WAS REPORTED: WE HAVE A LEAKING ISSUE WITH OUR P14 VIAL ADAPTORS WITH THE LOT NUMBER #2404123. WE HAVE 36 UNUSED ADAPTORS REMAINING IN THE BOX. WE WERE TOLD BY OUR DISTRIBUTOR THAT Y'ALL PREFER TO HANDLE THESE ISSUES DIRECTLY WITH US RATHER THAN THEM. I CALLED LAST WEEK BUT I HAVEN'T HEARD BACK YET. IF SOMEONE CAN CALL SO THAT WE CAN DISCUSS THE ISSUE AND WHAT TO DO MOVING FORWARD, THAT WOULD BE GREAT PER FOLLOW UP FROM CUSTOMER 14MAR2025: 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 21 FEB 2025 (2 ADAPTORS); 25 FEB 2025 (1 ADAPTOR); 26 FEB 2025 (3 ADAPTORS); 28 FEB 2025 (1 ADAPTOR). LOT # 2404123. ADDITIONAL INFORMATION: YES, THE LEAK IS BETWEEN THE ADAPTER AND THE VIAL. IT WAS ATTACHED USING THE ASSEMBLY FIXTURE. NO ONE WAS HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21728714 ↗
• MalfunctionMar 30, 2025Leak/Splash; Leak/Splash

  THE FOLLOWING WAS REPORTED: WE HAVE A LEAKING ISSUE WITH OUR P14 VIAL ADAPTORS WITH THE LOT NUMBER #2404123. WE HAVE 36 UNUSED ADAPTORS REMAINING IN THE BOX. WE WERE TOLD BY OUR DISTRIBUTOR THAT Y'ALL PREFER TO HANDLE THESE ISSUES DIRECTLY WITH US RATHER THAN THEM. I CALLED LAST WEEK BUT I HAVEN'T HEARD BACK YET. IF SOMEONE CAN CALL SO THAT WE CAN DISCUSS THE ISSUE AND WHAT TO DO MOVING FORWARD, THAT WOULD BE GREAT. PER FOLLOW UP FROM CUSTOMER 14MAR2025: 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 21 FEB 2025 (2 ADAPTORS); 25 FEB 2025 (1 ADAPTOR); 26 FEB 2025 (3 ADAPTORS); 28 FEB 2025 (1 ADAPTOR); LOT # 2404123. ADDITIONAL INFORMATION: YES, THE LEAK IS BETWEEN THE ADAPTER AND THE VIAL. IT WAS ATTACHED USING THE ASSEMBLY FIXTURE. NO ONE WAS HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21728713 ↗
• MalfunctionMay 3, 2024Leak/Splash; Leak/Splash

  MATERIAL# 515100 BATCH# UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT LEAK OUT OF THE TOP OF THE BOTTLE BETWEEN THE PROTECTOR AND THE BOTTLE VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. FULL NAME: (B)(6). ARE YOU A HEALTHCARE PROVIDER? NO. SPECIALTY: PHARMACEUTICALS. SPECIALTY OTHER: N/A. HOSPITAL/ORGANIZATION: AMATHEON ANIMAL HEALTH DEPARTMENT: PURCHASING STATE: (B)(6). POSTAL CODE: (B)(6). COUNTRY: UNITED STATES PHONE NUMBER: (B)(6). PHONE EXTENSION: (B)(6). EMAIL ADDRESS: (B)(6). INQUIRY TOPIC: FAULTY PHASEAL 515100 INQUIRY DETAILS: ON (B)(6) 2024, (B)(6) WAS OPENING A NEW BOTTLE OF MITOXANTRONE FOR A TREATMENT. SHE ADDED THE PHASEAL SATELLITE/PROTECTOR TOP TO THE BOTTLE, AND WAS ABLE TO START DRAWING UP THE MEDICATION, BUT PARTWAY THROUGH, PRESSURE SEEMED TO BUILD UP AND MITO SPILLED OUT OF THE BOTTLE, DRIPPING ONTO THE MATS IN THE HOOD AND SPRAYING ONTO (B)(6) CHEMO GOWN. IT SEEMED TO LEAK OUT OF THE TOP OF THE BOTTLE BETWEEN THE PROTECTOR AND THE BOTTLE. SHE DID NOT REPORT ANYTHING ABNORMAL LEADING UP TO THE CHEMO SPILL. I SAVED THE BOTTLE OF CHEMO WITH THE PHASEAL PROTECTOR ATTACHED AS WELL AS THE PACKAGING FOR BOTH IF WE NEED TO SEND IT IN FOR QUALITY CONTRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19242004 ↗
• MalfunctionJun 26, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR (P14) NEEDLE BENDS DURING AND AFTER PIERCING CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: THE NEEDLE OF THE PROTECTOR BENDS DURING/AFTER PIERCING THE SEPTUM --LEAKING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17200131 ↗
• MalfunctionJun 26, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR (P14) NEEDLE BENDS DURING AND AFTER PIERCING CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: THE NEEDLE OF THE PROTECTOR BENDS DURING/AFTER PIERCING THE SEPTUM --LEAKING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17200128 ↗
• MalfunctionMay 23, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD PHASEAL¿ PROTECTOR P14 LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING VIAL ADAPTORS (P14) ON THE SMALLER DRUG VIALS. WE HAVE HAD A VIAL LEAK ON US TODAY AFTER RECONSTITUTION: LOT # 2205101, BORTEZOMIB 3.5MG (B)(6) , NOT A VISCOUS DRUG, DRUG AT ROOM TEMPERATURE, THE ENTIRE VIAL HAD TO BE WASTED, ASSEMBLY FIXTURE WAS USED, ALSO HAPPENING WITH OTHER SMALL VIALS LIKE PEMBROLIZUMAB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16989954 ↗
• MalfunctionMar 30, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR P14 LEAKAGE OCCURED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: LEAKAGE OF CHEMO PRODUCT THROUGH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16653032 ↗
• MalfunctionMar 3, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE WITH 2 BD PHASEAL¿ PROTECTOR P14 LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WHEN SAMPLING FOR PRODUCT 515100 - WHEN THE PRODUCT WAS SAMPLED AND THEN RETURNED TO THE FIELD A LEAK OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16482225 ↗
• MalfunctionDec 2, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT HYCAMTIN LEAKED FROM BETWEEN THE BD PHASEAL¿ PROTECTOR (P14) AND VIAL DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS IS A REPORT ABOUT CHEMO LEAKAGE FROM THE CONNECTION TO THE PROTECTOR. ACCORDING TO THE CUSTOMER'S REPORT, DURING PREPARATION OF HYCAMTIN, THE FLUID LEAKAGE FROM THE CONNECTION BETWEEN THE PROTECTOR AND THE VIAL WAS OBSERVED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15911799 ↗
• MalfunctionNov 14, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD PHASEAL¿ PROTECTOR P14 LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: AFTER ATTACHING THE SECOND VIAL TO THE PROTECTOR, THE IDE TURNED THE SYSTEM HORIZONTAL TO INJECT AIR INTO THE SECOND VIAL. AT THIS POINT, THE IDE NOTICED A LEAK OF THE PRODUCT BETWEEN THE VIAL AND THE PROTECTOR. THE NURSE RECOVERED THE PRESCRIBED AMOUNT OF PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15789556 ↗
• MalfunctionOct 27, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT ONCOTICE LEAKED FROM THE BETWEEN THE BD PHASEAL¿ PROTECTOR (P14) AND VIAL AFTER BEING RECONSTITUTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ONCOTICE LEAKED FROM VIAL AFTER RECONSTITUTION - PHASEAL P14 PROTECTOR PLACED ON VIAL - 45ML OF SALINE WAS DRAWN INTO 50ML SYRINGE FROM SALINE BAG USING BLUNT TIP NEEDLE - NEEDLE WAS DISCARDED AND PHASEAL INJECTOR WAS PLACED ON 50ML SYRINGE - 50ML SYRINGE WITH INJECTOR WAS ENGAGED WITH PROTECTOR AND VIAL - 2-3ML OF SALINE PUSHED INTO VIAL - DRUG WAS GENTLY SWIRLED - VIAL WAS INVERTED TO BE ASPIRATED - DRUG STARTED LEAKING FROM THE VIAL (AT THE PROTECTOR AND VIAL CONNECTION)".

  Patient problems: Insufficient Information

  MAUDE report 15686513 ↗
• MalfunctionAug 11, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR P14 EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE PHASEAL IS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15210639 ↗
• MalfunctionJul 27, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR P14 EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER CONTINUES TO HAVE ISSUES WITH P-14 PROTECTORS NOT OPERATING CORRECTLY. SOMETIMES CHEMO LEAKS FROM THE DEICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15118022 ↗
• MalfunctionJul 8, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR P14 EXPERIENCED AN EXPANSION CHAMBER THAT BURST. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE USING PHASEAL PROTECTORP14 CORRECTLY, IT SPLIT CYTOSTATIC WITH FORCE TO HDW¿S HANDS. WHEN DRAWN DRUG FROM THE BOTTLE, THE BALLOON EXPLODED AND ALL DRUG SPILLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14960470 ↗
• MalfunctionMay 19, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR P14 LEAKED FROM THE EXPANSION CHAMBER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CLIENT: "PHASEAL PROTECTOR P14 LEAKED FROM THE EXPANSION CHAMBER, 3RD INCIDENT WITH THIS ITEM, SAME LOT NO. EXPOSURE TO LIVE VIRUS (BCG)."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14435513 ↗
• MalfunctionJun 28, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT PROTECTOR P14 LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECONSTITUTION OF BUSULFAN BY THE NURSE IN THE DEPARTMENT (BECAUSE OF THE WEEKEND). WEARING NITRILE GLOVES, GOWN, PLASTIC FOREARM PROTECTION. BOTTLE WAS PIERCED AND PREPARATION STARTED WITH THE SECURE SYSTEM WHEN I REALIZED THAT DROPS OF PRODUCT WERE RUNNING DOWN THE BOTTLE ONTO MY HAND. TINGLING SENSATION: GLOVES REMOVED, FINGERS IMMEDIATELY RINSED WITH WARM WATER , HAND WASHING WITH MILD SOAP. THEN ANOTHER NURSE (PROTECTION, DOUBLE PAIR OF GLOVES) TOOK OVER FOR THE END OF THE PREPARATION. DISPOSAL OF THE DEVICE IN THE BLUE CHEMO BOX. CONSEQUENCES FOR THE PATIENT: NONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12081149 ↗
• MalfunctionJan 25, 2019Fluid/Blood Leak

  IT WAS REPORTED THAT A SINGLE BD PHASEAL¿ PROTECTOR P14 EXPERIENCED LEAKAGE DURING USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8280051 ↗
• MalfunctionJun 29, 2018Occlusion Within Device

  IT WAS REPORTED THAT DURING THE TRANSFERRING OF THE FLUID BETWEEN THE P14 AND THE N35 THEY NOTICED FOR FEW BUBBLES IN THE SYRINGE WITH 1ML OF FLUID AND IT LOOKS STRANGE. THEY HAVE NOTICED FEW DROPS ON THE GLOVES AND ALSO ON THE OUTSIDE OF BD PHASEAL¿ PROTECTOR (P14) COMPONENTS. FOUND DURING USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7652591 ↗
• MalfunctionFeb 22, 2018Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR (P14) LEAKED DURING USE WHEN INVERTING THE VIAL FOR MEDICATION. NO REPORTS OR INJURY OR MEDICAL INTERVENTION NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7290960 ↗
• MalfunctionJan 9, 2018Disconnection; Fluid/Blood Leak; Unstable

  IT WAS REPORTED DURING USE THAT THE BD PHASEAL¿ PROTECTOR P14 DOES NOT FIT APPROPRIATELY INTO THE VIAL NECK AND IT IS NOT STABLE, MOVES AND TENDS TO GET EASILY DISCONNECTED AND CAUSE LEAKAGE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7175628 ↗