BD PhaSeal 515102Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00382905151026), received between Oct 24, 2017 and Nov 21, 2025 — classified as 35 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (11 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Contamination; Contamination

  EVENT DETAILS: IN THE CLINICAL TRIALS CARRIED OUT IN OUR COMPANY, THEBD PHASEAL¿ PROTECTOR P21 DEVICE, WHICH IS A PRODUCT OF YOUR COMPANY, IS USED. IN A CLINICAL RESEARCH CENTER, DURING THE DRUG PREPARATION PROCESS, THERE WERE NO VISIBLE PARTICLES IN THE LYOPHILIZED POWDER OR THE STERILE SOLUTION USED, WHILE BLACK PARTICLES WERE OBSERVED IN THE LIQUID MIXTURE AFTER MIXING THE POWDER AND SOLUTION USING THE BD PHASEAL¿ PROTECTOR P21 DEVICE. THIS SITUATION WAS REPEATED IN 6-7 DIFFERENT VIALS. WAS PATIENT OR USER HARMED? IF YES, PLEASE EXPLAIN WE DID NOT ADMINISTER DAMAGED RESEARCH PRODUCTS TO THE PATIENT. THEREFORE, OUR PATIENTS WERE NOT HARMED. WHAT MEDICATION VIALS IS THIS OCCURRING WITH? === MK-3120 LYOPHILIZED POWDER FOR INFUSION 100 MG/VIAL : MK-3120 LYOPHILIZED POWDER FOR SOLUTION FOR INFUSION IS A STERILE, NON-PYROGENIC POWDER SUPPLIED IN A SINGLE-USE TYPE I GLASS VIAL CONTAINING 100 MG/5 ML (20 MG/ML) OF MK-3120. THE PRODUCT IS A PRESERVATIVE-FREE, LATEX FREE SOLUTION WHICH IS ESSENTIALLY FREE OF EXTRANEOUS PARTICULATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23616967 ↗
• MalfunctionNov 21, 2025Contamination; Contamination

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23616964 ↗
• MalfunctionNov 21, 2025Contamination; Contamination

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23616963 ↗
• MalfunctionNov 21, 2025Contamination; Contamination

  EVENT DETAILS: IN THE CLINICAL TRIALS CARRIED OUT IN OUR COMPANY, THE BD PHASEAL¿ PROTECTOR P21 DEVICE, WHICH IS A PRODUCT OF YOUR COMPANY, IS USED. IN A CLINICAL RESEARCH CENTER, DURING THE DRUG PREPARATION PROCESS, THERE WERE NO VISIBLE PARTICLES IN THE LYOPHILIZED POWDER OR THE STERILE SOLUTION USED, WHILE BLACK PARTICLES WERE OBSERVED IN THE LIQUID MIXTURE AFTER MIXING THE POWDER AND SOLUTION USING THE BD PHASEAL¿ PROTECTOR P21 DEVICE. THIS SITUATION WAS REPEATED IN 6-7 DIFFERENT VIALS. WAS PATIENT OR USER HARMED? IF YES, PLEASE EXPLAIN WE DID NOT ADMINISTER DAMAGED RESEARCH PRODUCTS TO THE PATIENT. THEREFORE, OUR PATIENTS WERE NOT HARMED. WHAT MEDICATION VIALS IS THIS OCCURRING WITH? MK-3120 LYOPHILIZED POWDER FOR INFUSION 100 MG/VIAL: MK-3120 LYOPHILIZED POWDER FOR SOLUTION FOR INFUSION IS A STERILE, NON-PYROGENIC POWDER SUPPLIED IN A SINGLE-USE TYPE I GLASS VIAL CONTAINING 100 MG/5 ML (20 MG/ML) OF MK-3120. THE PRODUCT IS A PRESERVATIVE-FREE, LATEX FREE SOLUTION WHICH IS ESSENTIALLY FREE OF EXTRANEOUS PARTICULATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23616960 ↗
• MalfunctionAug 20, 2025Contamination; Contamination

  IT IS REPORTED FOREIGN MATTER. EVENT DESCRIPTION: WHILE PREPARING SEVERAL FORMULATIONS OVER THE PAST FEW DAYS, WE REPEATEDLY FOUND SMALL BLACK RUBBER PARTICLES IN OUR VIALS. THE ONLY COMMON FACTOR BETWEEN THE DIFFERENT PREPARATIONS WAS THE USE OF PROTECTOR P21 WITH LOT NUMBER 2501102. WHEN DID THE INCIDENT OCCUR? - DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22850852 ↗
• MalfunctionAug 14, 2025Contamination; Contamination

  IT IS REPORTED, CORING. EVENT DESCRIPTION: WHILE PREPARING SEVERAL BATCHES OVER THE PAST FEW DAYS, WE NOTICED THAT BLACK RUBBER PARTICLES (VERY SMALL) ENDED UP IN OUR VIALS ON SEVERAL OCCASIONS. THE ONLY THING THESE BATCHES HAD IN COMMON WAS THE USE OF PROTECTOR P21 WITH LOT NUMBER 2501102. HAVE YOU RECEIVED ANY OTHER REPORTS OF THIS PROBLEM? WE HAVE CURRENTLY QUARANTINED THE CONTENTS OF APPROXIMATELY EIGHT BOXES IN OUR CLEANROOM. PER CUSTOMER RESPONSE: IS THE PROTECTOR ASSEMBLED MANUALLY OR USING THE ASSEMBLY FIXTURE? USING THE ASSEMBLY FIXTURE. ARE THE PARTICLES OBSERVED AFTER ASSEMBLING THE PROTECTOR? IT WAS OBSERVED AFTER ASSEMBLING AND BEFORE DRAWING FLUID INTO THE SYRINGE. WHAT MEDICATION IS THIS OCCURRING WITH? REMSIMA, ENTYVIO AND ABEVMY. WHAT COLOR IS THE VIAL STOPPER? THEY ARE ALL GREY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22804247 ↗
• MalfunctionDec 13, 2024Leak/Splash; Leak/Splash

  THE PRODUCT LEAKS DURING USE. DURING USE. (B)(6) 2024 -BD REP - PLEASE VERIFY WHERE THE LEAK OCCURRED? BETWEEN THE PROTECTOR AND VIAL? BETWEEN THE INJECTOR AND PROTECTOR? IS THE PROTECTOR ASSEMBLED MANUALLY OR USING THE ASSEMBLY FIXTURE? IS THIS OCCURRING WITH A SPECIFIC MEDICATION? IF YES, WHAT MEDICATION? IT LEAKS WHEN YOU HAVE MIXED AND DRAW UP THE MIXTURE WITH THE SYRINGE, IF YOU SHAKE THE MIXTURE, IT DOES NOT LEAK IF YOU DO NOT SHAKE. THEY CANNOT BE USED BY THE MACHINE SO IT HAS MANUALLY ATTACHED THEM. (B)(6) 2025: YES, CUSTOMER CONFIRMED THAT A MISTAKE WAS MADE FROM THEIR SIDE AND IT SHOULD BE SKU 515102 ON (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20924888 ↗
• MalfunctionDec 5, 2024Leak/Splash; Leak/Splash

  THE PRODUCT LEAKS DURING USE. DURING USE. THE PRODUCT LEAKS DURING USE. DURING USE. IT LEAKS WHEN YOU HAVE MIXED AND DRAW UP THE MIXTURE WITH THE SYRINGE, IF YOU SHAKE THE MIXTURE, IT DOES NOT LEAK IF YOU DO NOT SHAKE. THEY CANNOT BE USED BY THE MACHINE SO IT HAS MANUALLY ATTACHED THEM. 19FEB2025: YES CUSTOMER CONFIRMED THAT A MISTAKE WAS MADE FROM THEIR SIDE AND IT SHOULD BE SKU 515102 ON PIR3020618 & PIR3020619. IT LEAKS WHEN YOU HAVE MIXED AND DRAW UP THE MIXTURE WITH THE SYRINGE, IF YOU SHAKE THE MIXTURE, IT DOES NOT LEAK IF YOU DO NOT SHAKE. THEY CANNOT BE USED BY THE MACHINE SO IT HAS MANUALLY ATTACHED THEM. 19FEB2025: YES CUSTOMER CONFIRMED THAT A MISTAKE WAS MADE FROM THEIR SIDE AND IT SHOULD BE SKU 515102 ON PIR3020618 & PIR3020619.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20855377 ↗
• MalfunctionJun 7, 2024Contamination; Contamination

  THEY FOUND A HAIR FROM PROTECTOR WHILE ATTACHED THE P21 IN TO THE VIAL A HAIR FOUND IN THE PROTECTOR. THIS IS ALREADY ATTACHED TO CHEMO VIAL. ONLY PICTURE AVAILLABLE NO PATIENT HARM DURING USE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19483124 ↗
• MalfunctionSep 19, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ OPTIMA PROTECTOR (P21) EXPERIENCED LEAKAGE BETWEEN PROTECTOR AND VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY HAD A LEAKAGE FROM THE PROTECTOR AND THE VIAL. THE FLUID CAME OUT BETWEEN THE VIAL AND THE PROTECTOR WERE THE PROTECTOR ARE CONNECTED TO THE MEMBRANE. I DON´T HAVE ANY PRODUCT TO SEND IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17776058 ↗
• MalfunctionJun 12, 2023Contamination; Contamination

  IT WAS REPORTED THAT DURING USE WITH BD PHASEAL¿ OPTIMA PROTECTOR (P21) FOREIGN MATTER WAS DISCOVERED. THIS IS THE 3RD OF 3 OCCURRENCES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: RECENTLY THERE HAVE BEEN 2 REPORTS IN A SHORT TIME THAT AFTER STORING THE RECONSTITUTED TRASTUZUMAB SEALED WITH A PHASEAL THERE ARE SMALL WHITE PARTICLES IN THE SOLUTION. THESE PARTICLES APPEAR TO BE FROM THE PHASEAL, AS THE PARTICLES ARE NOT PRESENT IMMEDIATELY AFTER RECONSTITUTION, AND WERE NOT OBSERVED UNTIL THE NEXT PREPARATION (THE NEXT DAY). WE STORED THE RECONSTITUTED TRASTUZUMAB WITH A PARTICLE IN A SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17114740 ↗
• MalfunctionJun 2, 2023Contamination; Contamination

  IT WAS REPORTED THAT THE BD PHASEAL¿ OPTIMA PROTECTOR (P21) CORED OUT PARTICLES INTO THE RECONSTITUTED TRASTUZUMAB SOLUTION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH: "RECENTLY THERE HAVE BEEN 2 REPORTS IN A SHORT TIME THAT AFTER STORING THE RECONSTITUTED TRASTUZUMAB SEALED WITH A PHASEAL THERE ARE SMALL WHITE PARTICLES IN THE SOLUTION... THESE PARTICLES APPEAR TO BE FROM THE PHASEAL, AS THE PARTICLES ARE NOT PRESENT IMMEDIATELY AFTER RECONSTITUTION, AND WERE NOT OBSERVED UNTIL THE NEXT PREPARATION (THE NEXT DAY). WE STORED THE RECONSTITUTED TRASTUZUMAB WITH A PARTICLE IN A SYRINGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17050223 ↗
• MalfunctionJun 2, 2023Contamination; Contamination

  IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR P21 EXPERIENCED FOREIGN MATTER, CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: RECENTLY THERE HAVE BEEN 2 REPORTS IN A SHORT TIME THAT AFTER STORING THE RECONSTITUTED TRASTUZUMAB SEALED WITH A PHASEAL THERE ARE SMALL WHITE PARTICLES IN THE SOLUTION. THESE PARTICLES APPEAR TO BE FROM THE PHASEAL, AS THE PARTICLES ARE NOT PRESENT IMMEDIATELY AFTER RECONSTITUTION, AND WERE NOT OBSERVED UNTIL THE NEXT PREPARATION (THE NEXT DAY).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17050220 ↗
• MalfunctionJan 4, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR P21 EXPERIENCED LEAKAGE BETWEEN THE PROTECTOR AND VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER HAD A LEAKAGE WITH THE PROTECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13156084 ↗
• MalfunctionDec 14, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED BD PHASEAL¿ PROTECTOR HAD ISSUES WITH LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A STRONG ANTIBIOTIC SPILL OCCURRED WHEN A LEAK OCCURRED BETWEEN THE BOTTLE AND A... PROTECTOR".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13003619 ↗
• MalfunctionJun 1, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PROTECTOR P21 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS MANUALLY PLACED ON A VIAL OF KADCYLA. THIS VIAL CONTAINS TRASTUZUMAB-EMTANSIN POWDER. WHILE DISSOLVING THE POWDER WITH AQUA FOR INJECTION, WE NOTICED A PARTICLE OF THE SEPTUM IN THE VIAL. CORRECT VOLUME WAS THEN WITHDRAWN VERY CAREFULLY BY SYRINGE FROM VIAL, MAKING SURE THAT PARTICLE REMAINED IN VIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11918100 ↗
• MalfunctionMay 28, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PROTECTOR P21 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BEFORE USING THE PHASEAL PROTECTOR THE PHARMACIST NOTICED A HAIR IN THE STERILE PACKAGING. THE PRODUCT WAS THEREFORE NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11899335 ↗
• MalfunctionFeb 1, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PROTECTOR P21 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER CAPPING THE VIAL, HAIR FOUND IN THE BALLOON. HAS CLEARLY ENDED UP THERE DURING PRODUCTION. THE PROTECTOR WAS ALREADY ATTACHED TO A VIAL OF KADCYLA 100 MG (¿1645) SO IT COULD NO LONGER BE USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11263456 ↗
• MalfunctionNov 5, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL" PROTECTOR P21 EXPERIENCED LEAKAGE BETWEEN THE PROTECTOR AND VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE PHASEAL P21. A NURSE WAS PREPARING PIPERACILLIN/TAZOBACTAM WITH PHASEAL PROTECTOR P21. WHEN SHAKING THE VIAL IT STARTED TO LEAK ON GLOVES, FLOOR AND TABLETOP. ACCORDING TO THE NURSE THE PROTECTOR WAS ASSEMBLED PROPERLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10796441 ↗
• MalfunctionOct 15, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PROTECTOR P21 EXPERIENCED NEEDLE SEPARATION ON THE PROTECTOR DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN TAKING OF THE INJECTOR FROM THE PROTECTOR , THE PROTECTOR WHITE PART CAME ALSO OF THE VIAL AND THE NEEDLE STAYED INSITE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10687584 ↗
• MalfunctionAug 14, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD PHASEAL¿ PROTECTOR P21 EXPERIENCED LIQUID IN THE EXPANSION CHAMBER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6), UNDER A LAMINAR FLOW HOOD, A P21 PROTECTOR (PHASEAL BD) WAS USED ON A CARMUSTINE BOTTLE, IT WAS RECONSTITUTED WITH ABSOLUTE ALCOHOL PLUS DOUBLE-DISTILLED WATER, AT THE TIME OF EXTRACTING THE RECONSTITUTED DRUG, MUCH OF IT WENT TO THE BAG THAT CONTAINS THE PROTECTOR (VAPOR SPACE), SO A LOT OF DRUG WAS LOST. THE LOSS WAS NOT IMPORTANT SINCE WHAT WAS LEFT WAS ENOUGH FOR THE DOSE REQUIRED FOR THE PATIENT. THERE WAS NO ADVERSE EVENT OR HARM TO THE PATIENT OR PREPARER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10411622 ↗
• MalfunctionMar 10, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PROTECTORS P21 EXPERIENCED FOREIGN MATTER/CORING OBSERVED IN VIAL OR FLUID PATH. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE THAT MIXED THE ANTIBIOTIC SAW AFTER PREPARATION A SMALL PIECE (CORING) IN THE BOTTLE. SHE DIDN'T GIVE IT TO THE PATIENT. THEY USED PIPERACILLIN/TAZOBACTIM 4G/0,5G FROM FRESENIUS (B)(4). THEY DIDN'T SAVE THE BOTTLE AND WE DIDN'T GOT ANY SAMPLE. ONLY THAT IT WAS PREPARED WITH PHASEAL PROTECTOR AND INJECTOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9813185 ↗
• MalfunctionMar 5, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A BD PHASEAL PROTECTOR P21 LEAKED BETWEEN THE PROTECTOR AND THE VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKAGE BETWEEN PROTECTOR AND VIAL WHEN THEY PREPARED ANTIBIOTICS. NO PATIENT INVOLVED."

  Patient problems: No Patient Involvement

  MAUDE report 9795526 ↗
• MalfunctionNov 6, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PROTECTOR P21S EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER SAW SMALL PIECES OF THE MEMBRANE IN 3 BOTTLES (CORING). IT HAPPENS WITH VANCOMYCIN 1G FROM PHARMACY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9285523 ↗
• MalfunctionJun 27, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROTECTOR P21 EXPERIENCED NEEDLE SEPARATION ON PROTECTOR PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPON OPENING OF THE PACKAGING, THE PHARMACIST NOTICE THERE'S LOST OF NEEDLE AFTER REMOVING THE CAP OF THE PROTECTOR. THUS, THE PRODUCT COULD NOT BE USE. UPDATED INFO: THE NEEDLE WAS NOT IN THE PACKAGING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8742130 ↗