BD PhaSeal 515105Recalls & reported problems
BD Switzerland Sàrl · Protector (P50) · Class 2
All models of BD PhaSeal (23)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This BD PhaSeal protector is part of a closed system for mixing and transferring chemotherapy and other hazardous drugs. The 71 reports that name its identifier mostly describe leaks, contamination, and bits of plastic or rubber or hair found inside the device or vials. There are no deaths and 2 injuries mentioned. There is 1 open recall started in June 2025 about devices shipped without U.S. instructions for use.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 71
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 00382905151057), received between Nov 14, 2017 and Aug 4, 2026 — classified as 2 injuries, 69 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (24 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.
Reports received per month
Recalls naming this device
- 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
Device problems
- Device Contamination with Chemical or Other Material24
- Leak/Splash16
- Contamination8
- Contamination /Decontamination Problem5
- Break4
- Fluid/Blood Leak3
- Defective Component2
- Detachment of Device or Device Component2
Patient problems
- No Known Impact Or Consequence To Patient31
- No Clinical Signs, Symptoms or Conditions25
- No Consequences Or Impact To Patient9
- No Information3
- No Patient Involvement3
- Chemical Exposure1
Recent adverse event reports
The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 4, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50131802 ↗MalfunctionJul 31, 2026Contamination
No additional information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50101617 ↗MalfunctionJan 6, 2026Contamination
EVENT DETAILS: IT WAS REPORTED THAT HAIR FOUND INSIDE THE CHAMBER. FOUND DURING USE. NEITHER PATIENT NOR USER WERE HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23974618 ↗MalfunctionAug 22, 2024Leak/Splash; Leak/Splash
MEDICAL DAY STAY ARE EXPERIENCING LEAKAGES AND FOREIGN MATTER BEING EITHER RUBBER VIAL STOPPER OR P50 PLASTIC MATERIAL GOING IN THE VIAL. THIS MEANS THEY CANNOT USE THE COMPOUNDED MEDICATION AND IT IS WASTING A LOT OF MONEY. THEY DO NOT HAVE A VIAL PRESS. THEY ALSO FOUND DUE TO THE LEAKAGES IT IS GOING INTO THE AREA WHERE THE PLASTIC FILM EXPANDS. THEY ARE ALSO FINDING ITS NOT BIG ENOUGH FOR THE VIAL CAUSING THE PLASTIC TO POSSIBLY SNAP OR CRACK. WE NEED TO FOLLOW UP WITH THE CUSTOMER AND SALES REP TO CLARIFY IF THIS IS ONE ISSUE THAT IS CAUSING OTHER PROBLEMS WITH THE DEVICE OR IF THEY ARE HAVING MULTIPLE ISSUES WITH THE PROTECTOR. WHERE IS THE LEAK OCCURRING? BETWEEN THE PROTECTOR AND VIAL OR INTO THE EXPANSION CHAMBER? IS THIS OCCURRING AFTER THE INITIAL USE OR AFTER MULTIPLE WITHDRAWALS FROM THE SAME VIAL? IS THE PROTECTOR NOT FITTING ONTO THE VIAL AND THUS CAUSING A LEAK? OR IS THIS A SEPARATE ISSUE THEY ARE EXPERIENCING? WHAT MEDICATION IS BEING USED WHEN THIS OCCURS? WHEN ARE THEY OBSERVING THE FOREIGN MATTER? AFTER ATTACHING THE PROTECTOR ONTO THE VIAL? 18-AUG-2024 FIRST FOLLOW UP EMAIL SENT TO COMPLAINANT FOR ADDITIONAL INFORMATION REQUESTED. (B)(4). 21-AUG-2024- RECEIVED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20044858 ↗MalfunctionAug 22, 2024Contamination; Contamination
MEDICAL DAY STAY ARE EXPERIENCING LEAKAGES AND FOREIGN MATTER BEING EITHER RUBBER VIAL STOPPER OR P50 PLASTIC MATERIAL GOING IN THE VIAL. THIS MEANS THEY CANNOT USE THE COMPOUNDED MEDICATION AND IT IS WASTING A LOT OF MONEY. THEY DO NOT HAVE A VIAL PRESS. THEY ALSO FOUND DUE TO THE LEAKAGES IT IS GOING INTO THE AREA WHERE THE PLASTIC FILM EXPANDS. THEY ARE ALSO FINDING ITS NOT BIG ENOUGH FOR THE VIAL CAUSING THE PLASTIC TO POSSIBLY SNAP OR CRACK WE NEED TO FOLLOW UP WITH THE CUSTOMER AND SALES REP TO CLARIFY IF THIS IS ONE ISSUE THAT IS CAUSING OTHER PROBLEMS WITH THE DEVICE OR IF THEY ARE HAVING MULTIPLE ISSUES WITH THE PROTECTOR. WHERE IS THE LEAK OCCURRING? BETWEEN THE PROTECTOR AND VIAL OR INTO THE EXPANSION CHAMBER? IS THIS OCCURRING AFTER THE INITIAL USE OR AFTER MULTIPLE WITHDRAWALS FROM THE SAME VIAL? IS THE PROTECTOR NOT FITTING ONTO THE VIAL AND THUS CAUSING A LEAK? OR IS THIS A SEPARATE ISSUE THEY ARE EXPERIENCING? WHAT MEDICATION IS BEING USED WHEN THIS OCCURS? WHEN ARE THEY OBSERVING THE FOREIGN MATTER? AFTER ATTACHING THE PROTECTOR ONTO THE VIAL? 18-AUG-2024 FIRST FOLLOW UP EMAIL SENT TO COMPLAINANT FOR ADDITIONAL INFORMATION REQUESTED. (B)(6). 21-AUG-2024- RECEIVED A
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20043815 ↗MalfunctionJun 25, 2024Defective Component; Defective Component
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19607654 ↗MalfunctionMay 21, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19365721 ↗MalfunctionMay 21, 2024Defective Component; Defective Component
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19365593 ↗MalfunctionFeb 2, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18633783 ↗MalfunctionDec 20, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
NO ADDITIONAL INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18363417 ↗MalfunctionOct 20, 2023Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17981484 ↗MalfunctionSep 6, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
WHEN COMPOUNDING IT'S BEEN NEWLY NOTICED THAT THERE IS DEFINITE CORING HAPPENING WHEN USING THE PROTECTOR CODE 515105 LOT 2207114. AND INJECTOR 515003 LOT 2212001. PENETRATION OF THE MEMBRANES ARE AT MOST 5 TIMES. THIS IS A NEW ISSUE, HAVE NOT HAPPENED IN PREVIOUS SESSIONS. STARTED USING PHASEAL IN COMPOUNDING FROM THE 17TH OF JULY 2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17691934 ↗MalfunctionMay 2, 2023Contamination; Contamination
IT WAS REPORTED THAT 2 BD PHASEAL¿ PROTECTOR P50 EXPERIENCED CORING AND PARTICLES FOUND IN THE DRUG VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ENDUSER USE BD PHASEAL FOR ONCOLOGY DRUG COMPOUNDING . PARTICLES HAVE BEEN FOUND IN DRUG VIAL X2 . PARTICLES ARE SUSPECTED TO BE CAUSED BY CORING WHEN USER INSERT BD PROTECTOR ONTO THE VIAL .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16853939 ↗MalfunctionApr 25, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT 2 BD PHASEAL¿ PROTECTORS P50 CAUSED CORING TO OCCUR IN THE MEDICATION VIALS DURING THE DRUG COMPOUNDING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ENDUSER USE BD PHASEAL FOR ONCOLOGY DRUG COMPOUNDING . PARTICLES HAVE BEEN FOUND IN DRUG VIAL X2. PARTICLES ARE SUSPECTED TO BE CAUSED BY CORING WHEN USER INSERT BD PROTECTOR ONTO THE VIAL.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16807287 ↗MalfunctionMar 22, 2023Contamination; Contamination
IT WAS REPORTED WHILE USING BD PHASEAL¿ DRUG VIAL ACCESS DEVICE FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SHE SAID THERE WAS NO LEAKING, JUST CORING. THE CUSTOMER IS FINDING THE ¿CORING¿ OF THE RUBBER VIAL UPON APPLICATION OF THE VIAL ACCESS DEVICE THE CUSTOMER BELIEVES THE CORING IS WORSE THAN NORMAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16592644 ↗MalfunctionMar 22, 2023Contamination; Contamination
IT WAS REPORTED WHILE USING BD PHASEAL¿ DRUG VIAL ACCESS DEVICE FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SHE SAID THERE WAS NO LEAKING, JUST CORING. THE CUSTOMER IS FINDING THE ¿CORING¿ OF THE RUBBER VIAL UPON APPLICATION OF THE VIAL ACCESS DEVICE. THE CUSTOMER BELIEVES THE CORING IS WORSE THAN NORMAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16592584 ↗MalfunctionMar 13, 2023Contamination; Contamination
IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR P50 EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PARTICLES HAVE BEEN FOUND IN DRUG VIAL X1 AND SALINE BAG X1 . PARTICLES ARE SUSPECTED TO BE CAUSED BY CORING WHEN USER INSERT BD PROTECTOR ONTO THE VIAL OR WHEN INSERTING INFUSION ADAPTOR INTO THE SALINE BOTTLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16530917 ↗MalfunctionSep 29, 2022Fluid/Blood Leak
IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR P50 WAS LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IS LEAKING DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15505811 ↗MalfunctionAug 5, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR P50 WAS LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING PREPARATION IN THE ISOLATOR, THE PHASEAL PROTECTOR SYSTEM DID NOT FIT ON THE CYCLOPHOSPHAMIDE VIAL. THE CYCLOPHOSPHAMIDE LEAKED (SPRAY) INTO THE ISOLATOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15174288 ↗MalfunctionJan 4, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR P50 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 13155711 ↗MalfunctionOct 28, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED BD PHASEAL¿ PROTECTOR 50 HAD A LEAKAGE ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "UPON STRIKING A VIAL OF CYCLOPHOSPHAMIDE WITH A PROTECTOR, THE OPERATOR NOTICES FLUID ON THE VIAL WHICH APPEARS TO BE FROM LEAKAGE RELATED TO THE INSERTION OF THE DEVICE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12713750 ↗MalfunctionOct 22, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED BD PHASEAL¿ PROTECTOR 50 HAD ISSUES WITH FOREIGN MATTER/CORING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NOW THEY REALIZED WHITE FLUFFY PARTICLES AND ONE GREY PARTICLE IN READY DRUG BAG AFTER USED PHASEAL SYSTEM:PROTECTOR, INJECTOR AND ADAPTER."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12683130 ↗MalfunctionSep 2, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED WHEN USING THE BD¿ PROTECTOR P50 THERE WAS FOREIGN MATTER/CORING OBSERVED IN THE VIAL OR FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE DISCOVERED RUBBER PARTICLES IN THE LIQUID WHEN USING A PROTECTOR ON FOLLOWING PRODUCTS: ERBITUX 500MG/100ML. RIXATHON 500MG/50ML."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12415456 ↗MalfunctionMar 27, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR P50 LEAKED MEDICINE FROM THE CONNECTION TO THE VIAL WHILE DRAWING IT UP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AFTER THE PHARMACIST ATTACHED THE P50 TO THE VIAL, AND DURING THE DRAWING OF DRUG, THE DRUG SEEMS TO BE LEAKING FROM THE SITE CONNECTION OF THE PROTECTOR AND THE VIAL. THE PHARAMCIST THEN PUTS THE DRUG INTO THE BAG AND SHAKE IT INSIDE THE BAG. DROPLETS FORMED INSIDE THE BAG INDICATING A LEAK. A SAMPLE COULD NOT BE SENT BACK AS IT IS CONTAMINATED WITH CYTOTOXIC DRUG.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11579863 ↗MalfunctionFeb 26, 2021Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT PROTECTOR P50 FILTER CAME LOOSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HYDROFOBIC FILTER CAME LOOSE OF THE PROTECTOR CAP. WHEN DID THE INCIDENT OCCUR? BEFORE USE HYDROFOBIC FILTER CAME LOOSE OF THE PROTECTOR CAP WHEN AIR WAS PUSHED INTO THE BALLOON.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11389250 ↗
Other Closed antineoplastic and hazardous drug reconstitution and transfer system devices
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- BD PhaSeal 515056BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall159 reports
- BD PhaSeal Optima 515070BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall154 reports
- Alaris 10012241-0500BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall138 reports
- BD PhaSeal 515005BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall128 reports
- ICU Medical CL3011Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system3 recalls26 reports
- BD PhaSeal Optima 515052BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall114 reports
- ICU Medical CL3511Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system3 recalls6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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