BD PhaSeal 515065Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00382905150654), received between Oct 31, 2020 and Sep 29, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938987 ↗
• MalfunctionSep 10, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50724560 ↗
• MalfunctionJan 9, 2026Nonstandard Device

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24020071 ↗
• MalfunctionJul 7, 2025Nonstandard Device; Defective Component; Nonstandard Device; Defective Component

  DESCRIPTION: IT IS REPORTED, CORING. 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? 6/24/25. 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 (13MM, 20MM, O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412564 ↗
• MalfunctionDec 5, 2024Leak/Splash; Leak/Splash

  MATERIAL # 515065. BATCH # 2407417. VERBATIM: WHEN ADDING AIR TO THE VIAL WHILE COMPOUNDING, THE INJECTOR (NON-LOCKING) AND SYRINGE POPPED OFF (STILL LURED TOGETHER) AND CAUSED CHEMO TO SHOOT OUT OF THE TOP OF THE MEMBRANE ON THE VIAL PROTECTOR. SHE CLARIFIED THAT THE SYRINGE AND INJECTOR NEVER SEPARATED, BUT THAT THE LEAK WAS MADE AFTER TOTALLY DISENGAGING THE MEMBRANES BETWEEN THE INJECTOR AND THE VIAL PROTECTOR. THE LOT NUMBER FOR THE PROTECTOR INVOLVED IN THE INCIDENT IS: 2407417 PRODUCTS#: 515064. ADDITIONAL INFORMATION RECEIVED ON 02DEC. YES, 515065 WOULD BE CORRECT. THERE WAS NO PATIENT INVOLVED IN THIS SITUATION. NO SERIOUS INJURY OCCURRED BUT THERE WAS EXPOSURE TO HAZARDOUS DRUG/CHEMO SPILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20854816 ↗
• MalfunctionSep 9, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  SHORT DESCRIPTION DRUG CONTAMINATION ON THE MEMBRANE DURING THE PREPARATIONS OF HAZARDOUS DRUGS THERE WAS A LIQUID CONTAMINATION ON THE MEMBRANE WHEN DID THE INCIDENT OCCUR? DURING USE ADDITIONAL INFORMATION: CAN YOU PROVIDE THE BATCH NUMBER OF THE DEFECTIVE PRODUCT? 2406408, 31/05/2026. CONFIRM THE NUMBER OF AFFECTED PRODUCTS. HAVE THERE BEEN ANY IMPACTS ON PATIENTS (SERIOUS INJURIES, MEDICAL INTERVENTIONS, NEED TO CHANGE TREATMENT)? NO WE WOULD LIKE YOU TO CONFIRM WHETHER SAMPLES ARE AVAILABLE FOR INVESTIGATION. IF SO, YOU CAN SPECIFY WHETHER THE SAMPLES ARE: - NOT USED (BEFORE USE) YES WITH NO-DRUG COLOURING SOLUTION (METHYLENE BLUE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20168363 ↗
• MalfunctionApr 24, 2024Break; Break

  MATERIAL# 515065. BATCH# UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THE MEMBRANE PORTION OF A 515065 P20-0 PROTECTOR BREAKING OFF WHILE TRYING TO PUSH SOLUTION INTO A VIAL. VERBATIM: CUSTOMER DESCRIBED 2 INSTANCES OF THE MEMBRANE PORTION OF A 515065 P20-0 PROTECTOR BREAKING OFF WHILE TRYING TO PUSH SOLUTION INTO A VIAL. PER CUSTOMER RESPONSE 23APR2024: I DO NOT KNOW WHAT THE LOT NUMBER WAS OF THIS PRODUCT. THE RESULT OF THE BREAK WAS A HAZARDOUS DRUG SPILL BOTH TIMES THE PROTECTORS BROKE. I DID NOT TAKE ANY PICTURES THE FIRST TIME IT BROKE. BOTH OF THESE PICTURES ARE FROM THE SECOND INCIDENT. I WAS USING IT MANUALLY. WE DO NOT HAVE THE ASSEMBLY FIXTURE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19174567 ↗
• MalfunctionNov 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED WHILE USING BD PROTECTOR P20-O MULTIPACK THE RUBBER STOPPER WAS PUSHED INTO THE VIAL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN PUTTING OPTIMA P20 PROTECTOR ONTO THE RITUXAN VIAL IN THE HOOD IN PHARMACY, THE RUBBER STOPPER CAVED INTO THE VIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15782769 ↗
• MalfunctionFeb 1, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT BD PHASEAL¿ OPTIMA PROTECTOR HAD THE EXPANSION CHAMBER BURST CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "  IT WAS REPORTED BY THE CONSUMER THE BUBBLE POPPED IN THE PHASEAL CAUSING LEAKAGE. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13416867 ↗
• MalfunctionJul 8, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A SMALL PIECE OF LOOSE "MEMBRANE" WAS FOUND ATOP THE BD PHASEAL¿ OPTIMA PROTECTOR (P20-O MULTI) MEMBRANE DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACY NOTICED TINY PIECE (GRAIN OF SAND SIZE) OF LOOSE MEMBRANE MATERIAL (OR SOMETHING?) SITTING ON TOP OF P20-O PHASEAL OPTIMA PROTECTOR MEMBRANE WHEN DISCONNECTING THE INJECTOR AFTER DRAWING UP DRUG. I, THE REP SAW IT TOO. THIS HAPPENED 4 TIMES. ALL THE INJECTORS CAME FROM THE SAME MULTIPACK PACKAGE - ¿ ETOPOSIDE ¿ TINY PIECE OF MEMBRANE OBSERVED ON TOP OF C100 PROTECTOR MEMBRANE AFTER DRAWING UP MEDICATION. ¿ IRINOTECAN ¿ 4 VIALS. PROTECTOR AND INJECTOR ON VIAL #4 HAVE SMALL VISIBLE HOLES FROM INJECTOR NEEDLE. AGAIN, A TINY PIECE OF MEMBRANE OBSERVED ON TOP OF PROTECTOR MEMBRANE. ¿ VELCADE ¿ SUBQ SYRINGE. AGAIN, A TINY PIECE OF MEMBRANE OBSERVED ON TOP OF PROTECTOR MEMBRANE. ¿ ALIMTA ¿ 5 VIALS / RECONSTITUTED POWDER. FIRST ACCESS TO DILUENT BOTTLE HAD A TINY PIECE OF MEMBRANE OBSERVED ON TOP OF PROTECTOR MEMBRANE. ADAPTER MEMBRANE ON BAG HAD A LOT OF SHINE AFTER DRUG WAS ADDED WITH THE INJECTOR THAT HAD BEEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12140354 ↗
• MalfunctionJun 30, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT PROTECTOR P20-O MULTIPACK LEAKED. THIS OCCURRED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE SALES REP THAT THERE IS LEAKAGE THROUGH THE MEMBRANE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12097524 ↗
• MalfunctionOct 31, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD PHASEAL OPTIMA PROTECTOR (P20-O MULTI) LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DATE RECEIVED FOR INTAKE: (B)(6) 2020, MATERIAL NO. 515065, BATCH NO. 2001102. IT WAS REPORTED THAT AFTER THE PROTECTOR WAS PLACE ON THE VIAL, LEAK AND DROP APPEARED BETWEEN THE PROTECTOR SLEEVE AND THE VIAL RUBBER STOPPER. PER PIR: "IT WAS REPORTED THAT AFTER THE PROTECTOR WAS PLACE ON THE VIAL, LEAK AND DROP APPEARED BETWEEN THE PROTECTOR SLEEVE AND THE VIAL RUBBER STOPPER."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10767165 ↗