BD PhaSeal Optima 515053Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 30382905150532), received between Oct 27, 2020 and Sep 17, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (6 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.

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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Break

  The following information was provided by the initial reporter:It was reported that after infusing normal saline into the Abraxane vial, user attempted to collect the solution by connecting a syringe with an injector to the protector. However, the threaded connection between the injector and the syringe broke, so they stopped using it and used a different product instead.Additional information provided:I understand that the damage occurred during the collection process, so I believe that some of the information leaks out.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50801727 ↗
• MalfunctionFeb 24, 2026Contamination

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24437459 ↗
• MalfunctionDec 23, 2025Disconnection; Leak/Splash; Disconnection; Leak/Splash

  EVENT DETAILS: DISCONNECTION BETWEEN ALARIS TUBING AND OPTIMA INJECTOR LEADING TO CHEMO SPILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23879664 ↗
• MalfunctionDec 2, 2025Disconnection; Leak/Splash; Disconnection; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694256 ↗
• MalfunctionJul 28, 2025Disconnection; Disconnection

  IT IS REPORTED, LUER LOCK BREAKAGE. EVENT DESCRIPTION: DURING COMPOUNDING OF CISPLATIN. NEW CISPLATIN VIAL NEW VIAL PROTECTOR P28 LOT: 2502706 NEW INJECTOR (MULTIPACK) LOT: 2501301 NEW SYRINGE MONOJECT. VIAL PROTECTOR ATTACHED TO NEW CISPLATIN VIAL. AIR ADDED TO SYRINGE. INJECTOR APPLIED. INJECTOR & SYRINGE ATTACHED DOWN ONTO VIAL PROTECTOR WHILE TRYING TO INJECT AIR - MET WITH RESISTANCE. TECH ADDED A LITTLE MORE PRESSURE. SYRINGE BROKE FROM INJECTOR, BUT INJECTOR REMAINED ON VIAL PROTECTOR & VIAL. CISPLATIN FLOWED UP THROUGH THE OPEN INJECTOR AND ONTO THE BSC. EXPOSURE TO HAZARDOUS DRUGS. ADDITIONAL INFORMATION 1. DID THE EXPANSION CHAMBER INFLATE WHEN ADDING AIR INTO THE VIAL? NO 2. WHAT WAS THE VOLUME OF MEDICATION TO BE WITHDRAWN? 50ML 3. HOW MUCH AIR WAS INJECTED BEFORE MEETING RESISTANCE? 50ML 4. DID THE LUER OF THE INJECTOR BREAK? OR DID ONLY THE SYRINGE BREAK OFF? THE SYRINGE BROKE AT THE LUER LOCK 5.I S THE SYRINGE A STANDARD LUER LOCK? YES 6. IS THE SYRINGE A BD PRODUCT? IF YES, WHAT IS THE MATERIAL INFORMATION? UNCLEAR WHICH SYRINGE WAS BEING USED AT THE TIME. 1. WAS THE APPROPRIATE PPE IN USE WHEN THE EXPOSURE OCCURRED? YES. 2. WAS THERE ANY INTERVENTION REQUIRED FOR T

  Patient problems: Chemical Exposure

  MAUDE report 22636168 ↗
• MalfunctionFeb 18, 2025Leak/Splash; Leak/Splash

  DESCRIPTION/EVENT DETAIL: IN THE PHARMACY CYTOSTATIC PRODUCTION AREA I HAD A COMMENT THAT THEY HAVE SEEN DROPS IN PHASEAL INJECTORS MEMBRANE AFTER USAGE (AFTER INJECTING CYTOSTATIC TO IV-BAG). DURING USE NO SAMPLES OR LOT AVAILABLE. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21405464 ↗
• MalfunctionJun 6, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IFU DOES NOT INCLUDE THE DATE OF ISSUE OR DATE OF REVISION. ACCORDING TO EU REG. 2017/745 THE INSTRUCTIONS FOR USE SHALL CONTAIN, AMONG OTHERS, DATE OF ISSUE OF THE INSTRUCTIONS FOR USE OR, IF THEY HAVE BEEN REVISED, DATE OF ISSUE AND IDENTIFIER OF THE LATEST REVISION OF THE INSTRUCTIONS FOR USE. INITIAL USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19475607 ↗
• MalfunctionDec 20, 2023Defective Device; Defective Device

  ADDITIONAL INFORMATION RECEIVED: WE APOLOGIZE WE DIDN¿T SAVE THE MALFUNCTION PRODUCT DUE TO CONTAMINATION. SO FAR WE HAVEN¿T HAD ANY MORE INCIDENT SINCE THAT ONE TIME. THANK YOU FOR YOUR FOLLOW UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18369032 ↗
• MalfunctionJan 5, 2023Break; Break

  IT WAS REPORTED THAT THE BD PHASEAL¿ OPTIMA INJECTOR (N35-O MULTI) EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TECH WAS FINISHING STEP OF ADDING DRUG INTO BAG, AS HE PULLED PHASEAL OPTIMA N-35 TO REMOVE INJECTOR FROM PHASEAL OPTIMA ADAPTOR (C100), THE END OF THE WHITE TIP FELL APART FROM THE REST OF WHITE END, RESULTED IN SPRING AND PARTS INSIDE OF INJECTOR FALLING OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16110111 ↗
• MalfunctionDec 12, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED BY CUSTOMER THAT 2 BD PHASEAL¿ OPTIMA INJECTOR (N35-O MULTI) WERE LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAD A REPORT FROM PHARMACY MANAGER AT ______ THAT THEY EXPERIENCED LEAKING ON 2 OCCASIONS WITH BD OPTIMA INJECTOR # 515053.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15958261 ↗
• MalfunctionSep 9, 2022Crack; Crack

  IT WAS REPORTED THAT THE BD PHASEAL¿ OPTIMA INJECTOR (N35-O MULTI) CRACKED WHEN DETACHING IT FROM THE VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AFTER PULLING THE DRUG INTO THE SYRINGE IT BROKE WHEN SHE DETACHED THE N35 FROM THE VIAL AND IT BROKE... THE CRACK RIGHT AT THE WHITE PART AT THE END OF THE N35."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397003 ↗
• MalfunctionAug 8, 2022Break; Break

  IT WAS REPORTED THAT THE BD PHASEAL¿ OPTIMA INJECTOR (N35-O MULTI) EXPERIENCED NEEDLE EXPOSURE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WANTED TO BRING TO YOUR ATTENTION AN ISSUE WE HAD WITH AN OPTIMA INJECTOR YESTERDAY. INJECTED A HAZARDOUS DRUG INTO A BAG, AND WHEN HE PULLED THE SYRINGE OFF THE INFUSION ADAPTER, THE SEAL CAME OUT OF THE INJECTOR LEAVING THE NEEDLE EXPOSED WITHIN THE INJECTOR SLEEVE. SEAL PIECE FROM INSIDE THE INJECTOR SLEEVE IS ON TOP OF THE PACKAGING. I AM NOT SURE IF ANYONE ELSE HAS HAD THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15182855 ↗
• MalfunctionJul 28, 2022Break; Break

  IT WAS REPORTED THAT WHILE USING A BD PHASEAL¿ OPTIMA INJECTOR (N35-O MULTI), THERE WAS NEEDLE EXPOSURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: XXXX INJECTED A HAZARDOUS DRUG INTO A BAG, AND WHEN HE PULLED THE SYRINGE OFF THE INFUSION ADAPTER, THE SEAL CAME OUT OF THE INJECTOR LEAVING THE NEEDLE EXPOSED WITHIN THE INJECTOR SLEEVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15127246 ↗
• MalfunctionMar 22, 2021Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ OPTIMA INJECTOR (N35-O MULTI) WAS DAMAGED AND MISSING THE POLYSOPRENE MEMBRANE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: DETECTED A NON-CONFORMITY IN PHASEAL OPTIMA INJECTOR -N35-O MULTIPACK. THE DEVICE IS MISSING THE POLYSOPRENE MEMBRANE THAT PROTECTS THE NEEDLE INSIDE THE INJECTOR BODY. HAS NOT BEEN USED. NO IMPACT ENCOUNTERED, THE OPERATOR NOTICED THE LACK OF POLYSOPRENE MEMBRANE BEFORE PROCEEDING TO HANDLE THE ANTIBLASTIC DRUG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11548142 ↗
• MalfunctionOct 27, 2020Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ OPTIMA INJECTOR (N35-O MULTI) "FELL APART" WHEN CONNECTED WITH THE PROTECTOR DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AFTER DRUG EXTRACTION THE INJECTOR N35-0 WAS FALLING APART WHEN CONNECTED WITH THE PROTECTOR. MEMBRANE AND SPRING WAS REMOVED FROM THE SHIELD AND ONE PIECE OF THE INJECTOR STAYED ON THE PROTECTOR". "YES THE PRODUCT WAS USED FOR CHEMOTHERAPY DRUG ¿ PERJETA."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10743820 ↗