BD PhaSeal Optima 515060Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00382905150609), received between Mar 29, 2019 and Aug 12, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Nonstandard Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50229529 ↗
• MalfunctionJul 21, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25895199 ↗
• MalfunctionFeb 2, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD PROTECTOR P13-O HAD LEAKAGE BETWEEN THE PROTECTOR AND THE VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT HAD BEEN REPORTED THAT THERE HAD BEEN MEDICATION LEAKAGE FROM THE VIAL AND PROTECTOR INSERTION SITE WHILE USING P13-O. (01/29-2026-NEHA PRASAD) PLEASE CONFIRM IF THE PROTECTOR IS ASSEMBLED MANUALLY OR USING THE ASSEMBLY FIXTURE? WHAT MEDICATION WAS BEING USED DURING THIS EVENT? WAS THERE ANY USER HARM? --A JIG WAS USED, BUT IT IS UNCLEAR IF IT WAS USED FOR THE APPROPRIATE CHEMICAL AGENT. THE CHEMICAL AGENT IS DIFORTA. THE USER WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24241974 ↗
• MalfunctionJan 29, 2026Leak/Splash

  PER ADDITIONAL RESPONSE FROM REP: - WHAT PRODUCTS FAILED THE TEST? WAS IT THE INJECTOR ONLY? THEY TESTED INJECTOR + PROTECTOR AND INJECTOR + CONNECTOR - WHEN PERFORMING THE TEST, HOW DID THEY GET THE PAPER UP TO THE MEMBRANE OF THE INJECTOR? NO INFORMATION AVAILABLE, THEY DID NOT SHARE TESTING DETAILS - DO YOU KNOW IF THEY OVER PRESSURIZED THE PROTECTOR? NO INFORMATION AVAILABLE, THEY DID NOT SHARE TESTING DETAILS - WAS THE TEAM IN GENT TRAINED ON OPTIMA? NOT RECENTLY. LAST TRAINING AND TRIAL WAS IN (B)(6) 2019 (B)(6) 2020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24218239 ↗
• MalfunctionJul 28, 2025Contamination; Contamination

  DESCRIPTION: IT WAS REPORTED BY CUSTOMER PRECIPITANT IN THE BAG. EVENT DETAILS: TODAY WE HAVE HAD SEVERAL ISSUES WITH PRECIPITANTS AND PLASTICS IN THE BAGS. WE HAD A TOTAL OF (B)(4) 200 MG KEYTRUDA BAGS ((B)(6) A PIECE), (B)(4) 1500 MG IMFINZI BAG ((B)(6)) AND (B)(4) 420 MG PERJETA BAGS ((B)(6) A PIECE). WE ALSO HAD (B)(4) KEYTRUDA VIALS ((B)(6)) THAT HAVE PRECIPITANT AFTER THE VIAL WAS SPIKED WITH VIAL ADAPTERS (LOT#2410402). HOWEVER, WHEN WE TROUBLESHOT THE COMPOUNDING OF ONE OF OUR KEYTRUDA BAGS, WE INJECTED KEYTRUDA ONLY WITH NEEDLES AND SPIKED THE SECONDARY SET, BUT WE STILL HAD PRECIPITATION IN THE BAG. THE BAG SPIKE LOT # 2405504. WE'RE JUST GRASPING AT STRAWS TO FIGURE OUT WHY THIS OCCURRED. ADDITIONAL INFORMATION: IT IS VERY DIFFICULT TO SEE BUT IT LOOKS LIKE MICROPARTICLES SUSPENDED IN SOLUTION. COULD BE DRUG OR AIR BUBBLES, BUT I WANT IT TESTED TO BE SAFE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22636658 ↗
• 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? 6/24/2025. 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,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412838 ↗
• MalfunctionApr 17, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860675 ↗
• MalfunctionMar 19, 2025Contamination; Contamination

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21646284 ↗
• MalfunctionNov 7, 2024Break; Break

  THE NEEDLE WHICH PUNCTURES THE VIAL SNAPPED WHILE ATTEMPTING TO ATTACH IT TO A VIAL. THEY USE THE ASSEMBLY FIXTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20630232 ↗
• MalfunctionJun 25, 2024Device 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 19604230 ↗
• MalfunctionJun 14, 2023Unintended Ejection; Unintended Ejection

  IT WAS REPORTED THAT DURING USE WITH BD PHASEAL¿ OPTIMA PROTECTOR P13-O THE RUBBER STOPPER DISLODGES INTO VIAL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE OPTIMA ASSEMBLY FIXTURE WAS USED WITH THE P13-O TO SPIKE A VIAL OF VECTIBIX. THIS VIAL HAS A FLAT VIAL STOPPER. THIS WAS A VETERAN STAFF MEMBER WHOM IS FAMILIAR WITH THIS SYSTEM. THE RUBBER STOPPER PUSHED ALL THE WAY INTO THE VIAL. THIS IS THE FIRST TIME THIS HAS HAPPENED WITH THIS VIAL AND OUR P13-O.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17131479 ↗
• MalfunctionApr 11, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED WHILE USING BD PHASEAL OPTIMA PROTECTOR (P13-O) THERE WAS A DISCREPANCY BETWEEN WHAT WAS ORDERED AND WHAT WAS RECEIVED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED ISSUE PER CUSTOMER: CUST CARRIE ZABAWA ORDERED 1 CS B-D515060, THE BOX WAS LABELED CORRECTLY BUT THE ITEM INSIDE WAS A DIFFERENT ITEM. A REPLACEMENT ORDER HAS ALREADY BEEN ENTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16713673 ↗
• MalfunctionApr 6, 2023Contamination; Contamination

  IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR P13-O EXPERIENCED FOREIGN MATTER, CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS LOOKS LIKE LITTLE WHITE PARTICLES THAT ARE ON THE CSTD ITSELF. I¿VE ATTACHED A PHOTOGRAPH OF THE INJECTOR WHERE THIS HAS HAPPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16695314 ↗
• MalfunctionMar 22, 2023Contamination; Contamination

  IT WAS REPORTED WHILE USING BD PHASEAL OPTIMA PROTECTOR THE RUBBER DISLODGED INTO THE VIAL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VIAL WHERE THE ADAPTER PUSHED IN THE STOPPER A LITTLE BIT AND THEY WERE NOT ABLE TO PUT DILUENT INTO THE VIAL. USING P13-O.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16592721 ↗
• MalfunctionFeb 22, 2023Break; Break

  IT WAS REPORTED WHILE USING BD PHASEAL OPTIMA PROTECTOR (P13-O) BREAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PROTECTOR SKIRT FLEW OFF THE VIAL CAP AND BROKE OFF. THEY SPIKED 4 VIALS TODAY AND OUT OF 4 VIALS , 1 HAD BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16415270 ↗
• MalfunctionFeb 14, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SPIKE OF THE BD PHASEAL¿ OPTIMA PROTECTOR (P13-O) WAS BENT AND LOOSE, AND THE RUBBER COVER OF THE VIAL SPIKE WAS ALSO DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PLASTIC SPIKE IS BENT AND LOSE AND THE RUBBER COVER OF THE VIAL SPIKE IS SQUISHED UP. THEY USED THE M12-O ASSEMBLY FIXTURE, IT IS BRAND NEW. THE MEDICATION THAT THEY WERE TRYING TO SPIKE WAS TAXIL IV - SANDOZ BRAND 5ML VIAL SIZE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16375220 ↗
• MalfunctionDec 22, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ OPTIMA PROTECTOR (P13-O) LEAKED WHILE EXTRACTING MEDICATION FROM THE VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "P-13 LEAKED DURING DRUG EXTRACTION FROM VIAL".

  Patient problems: Chemical Exposure

  MAUDE report 16032179 ↗
• MalfunctionJun 30, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD PHASEAL¿ OPTIMA PROTECTOR EXPERIENCED FOREIGN MATTER WITHIN THE VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN USING THE P13-O PROTECTOR, THERE WAS WHITE PARTICULATE WITHIN THE VIAL OF PANITUMUMAB. NO PATIENT IMPACT, BUT THEY HAVE HAD TO WASTE THIS DRUG AND THIS IS VERY EXPENSIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14877219 ↗
• MalfunctionJun 29, 2022Break; Break

  IT WAS REPORTED THAT THE SKIRT WAS BROKEN ON THE BD PHASEAL¿ OPTIMA PROTECTOR P13-O. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PLASTIC SKIRT AROUND THE VIAL BROKE AND CAME OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14860967 ↗
• MalfunctionFeb 3, 2021Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT PROTECTOR P13-O WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 515060, BATCH NO.: 2008404. IT WAS REPORTED THAT A PIECE BROKE OFF OF THE P13-O. PER PIR: P13-O HAD A PIECE BREAK OFF - IT WAS NOTICED WHEN THE PROTECTOR WAS PLACED IN THE ASSEMBLY FIXTURE THE TECHNICIAN NOTICED A PIECE FALL. THEY BELIEVE IT WAS THE PLASTIC SPIKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11274737 ↗
• MalfunctionMar 27, 2020Volume Accuracy Problem; Infusion or Flow Problem; Volume Accuracy Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT FLOW ISSUES OCCURRED DURING USE WITH A BD PHASEAL OPTIMA PROTECTOR (P13-O). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THIS COMPLAINT PERTAINS TO THE DOSAGE INACCURACIES REPORTED WHEN USING THE INJECTOR/PROTECTOR MATERIAL NO. 515060 BATCH NO. 1908105 IT WAS REPORTED THAT IS WAS DIFFICULT TO DISENGAGE. "INFORMATION LEARNED FROM LEAD PHARMACY TECHNICIAN REPRESENTING EIGHT PHARMACY TECHNICIANS DURING THE 30 DAY POST OPTIMA CSTD CONVERSION MEETING BACKGROUND: SITE BEGAN USING PHASEAL , NOVEMBER 2010 NO VOICED OR DOCUMENTED ERGONOMIC CONCERNS WITH USING PHASEAL PREPARATIONS VOLUME : 85 PTS .A DAY AT 2.5 DOSES AVERAGED PER PATIENT THIS WAS QUOTED BY PHARMACIST MANAGER = 212 DOSES A DAY OR 552, 50 DOSES A YEAR. LEAD PHARMACY TECHNICIAN DETAILED THE ERGONOMIC CONCERN WHEN MOVING FROM PHASEAL TO OPTIMA DECEMBER, 2019 DIFFICULT TO DISENGAGE INJECTORS FROM PROTECTOR, INJECTORS FROM INFUSION ADAPTER RESULTING IN EXPERIENCING SORE SHOULDERS AND NECK AND THUMBS . DEGREE OF DIFFICULTY TO DISENGAGE NOTICEABLE MORE THAN WHEN PREPARING WITH PHASEAL VERBALIZED BY ALL ALL NINE PHARMACY TECHNICIANS . ALL PHARMACY TECHNICIANS HAVE MENTIONED THE DIFFICULTY TO DI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9891973 ↗
• MalfunctionOct 10, 2019Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT MEDICATION DID NOT FLOW WITH COMPLETELY INTO VIAL WITH ONE INJECTION WITH A BD PHASEAL OPTIMA PROTECTOR (P13-O). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE MEDICATION WAS HAVING TROUBLE FLOWING COMPLETELY INTO THE VIAL WITH ONE INJECTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9174988 ↗
• MalfunctionOct 10, 2019Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THERE WAS FLOW ISSUES WHERE THE INJECTOR APPEAR TO BE DRAWING MEDICATION BACK INTO THE VIAL WITH A BD PHASEAL OPTIMA PROTECTOR (P13-O). THE FOLLOWING INFORMATION WAS PROVIDED BY THE COMPANY REPORTER: (3 OF 4 COMPLAINTS) IT WAS REPORTED THAT THE MEDICATION WAS HAVING TROUBLE FLOWING COMPLETELY INTO THE VIAL WITH ONE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE NOTICING THAT THE INJECTORS SEEM TO BE PULLING DRUG BACK INTO THE VIAL AFTER WE HAVE DETACHED THE SYRINGE WITH THE AMOUNT WE HAD NEEDED CAUSING US TO HAVE TO BACK INTO THE VIAL A FEW TIMES TO GET THE DESIRED AMOUNT TO STAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9174894 ↗
• MalfunctionMar 29, 2019Mechanical Problem

  IT WAS REPORTED THAT WHEN PREPARING PRALATREXATE, THE BLUE ADAPTOR OF A BD¿ PROTECTOR P13-O WAS ADDED TO VIAL, AND IT PUSHED THE RUBBER STOPPER RIGHT THROUGH INTO THE VIAL. CUSTOMER¿S VERBATIM: ¿ WHEN PREPARING PRALATREXATE, ADDED BLUE ADAPTOR TO VIAL AND IT PUSHED THE RUBBER STOPPER RIGHT THROUGH INTO THE VIAL. UNABLE TO USE DRUG, WHICH IS SUPPLIED COMPASSIONATELY. STILL HAD ENOUGH DRUG TO GIVE PATIENT¿S DOSE TODAY. ¿

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8466236 ↗