BD PhaSeal Optima 515070Recalls & reported problems

Summary

The FDA's MAUDE database contains 154 adverse event reports that list this exact device (DI 00382905150708), received between Sep 16, 2019 and Sep 28, 2026 — classified as 154 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (89 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 25 most recent of 154 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923622 ↗
• MalfunctionSep 25, 2026Connection Problem

  The following information was provided by the initial reporter:It was reported that anticancer drugs were administered via a C35-0 attached to a Safe T cannula, which was selected for compatibility with the Safe T port. Approximately 30 minutes after the start of administration, the patient exhibited abnormal symptoms. Upon investigation, it was determined that air was entering through the connection point and had entered the patient¿s bloodstream. Although appropriate measures prevented a serious outcome, this was an event that could have led to a life-threatening risk. The C35-0 attached to the Safe-T cannula was connected at an angle. While an installation error is highly likely, the possibility of a defect in the C35-0 itself cannot be ruled out, so we would like this to be verified.Additional information received on 25 Sep 2026Sales Rep mentioned that:It is unclear whether a standalone Safe T-port is being connected to another manufacturer¿s IV set or whether an integrated IV set is being used.It¿s possible that the connection was made at an angle. This appears to be primarily a manual error, such as a misalignment during assembly.I didn't check myself, but it seems a nurse wh

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896547 ↗
• MalfunctionSep 17, 2026Leak/Splash

  The following information was provided by the initial reporter:Customer advised that there was a leak of Azacitidine when being delivered via subcutaneous injection from phaseal optima to needle connection. advised that they put needle onto the connector then into the injector as recommended.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50804191 ↗
• MalfunctionSep 17, 2026Leak/Splash

  The following information was provided by the initial reporter:Customer advised that there was a leak of Azacitdine when being delivered via subcutaneous injection from phaseal optima to needle connection.advised that they put connector into injector then added needle to connector. Provided education of the order in which it needs to be connected- needle into connector then connector into injectorAdditional information:The leak occurred after assembling and when the therapy was being administered.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802865 ↗
• MalfunctionSep 11, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50744626 ↗
• MalfunctionSep 8, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50679683 ↗
• MalfunctionSep 4, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50620013 ↗
• MalfunctionSep 2, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50563779 ↗
• MalfunctionSep 2, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50554666 ↗
• MalfunctionAug 18, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50307905 ↗
• MalfunctionAug 13, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50244603 ↗
• MalfunctionAug 6, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50168521 ↗
• MalfunctionAug 6, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50168516 ↗
• MalfunctionMay 5, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD INJECTOR LOCKING N40-O HAD LEAKAGE AT THE LUER. COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED I AM NOT SURE IF YOU ARE THE ONE WHO CAN HELP ME WITH THIS, BUT I WOULD LIKE AN INSERVICE ON THE PHASEAL FOR MY UNIT AS THERE STILL SEEMS TO BE SOME ISSUES WITH LEAKAGE THAT I THINK IS RELATED TO USER ERROR. I FEEL LIKE AN IN-SERVICE WILL HELP WITH THE ISSUES WE ARE EXPERIENCING. LET ME KNOW IF YOU CAN HELP ME WITH THIS. I APPRECIATE YOU! PER FULL EMAIL: I WANTED TO SEND OUT THIS EDUCATION AGAIN TO HELP KEEP EVERYONE SAFE. I HAVE INCLUDED ALL RNS FOR SITUATIONAL AWARENESS AND MANY OF YOU ARE NOT CHEMOTHERAPY PROVIDERS YET BUT ARE GOING THROUGH THE ONCOLOGY TIPS PROGRAM SO IT WILL BE GOOD INFORMATION FOR THE FUTURE. SITUATION: WE HAVE EXPERIENCED A FEW ADDITIONAL CHEMOTHERAPY DISCONNECTIONS AND SPILLS ON OUR UNIT INVOLVING PHASEAL CONNECTORS SINCE OUR PREVIOUS EDUCATION WAS SHARED. BACKGROUND: OVER THE PAST YEAR, THERE HAVE BEEN MULTIPLE DOCUMENTED CHEMOTHERAPY SPILLS RELATED TO PHASEAL CONNECTOR USE. EDUCATION WAS PREVIOUSLY PROVIDED AFTER CONSULTATION WITH BD PRODUCT EDUCATORS REGARDING PROPER CONNECTION TECHNIQUE. ASSESSMENT: REVIEW OF RECENT EVENTS CONTINUES TO SHOW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25085995 ↗
• MalfunctionMay 5, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD INJECTOR LOCKING N40-O HAD LEAKAGE AT THE LUER. COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED I AM NOT SURE IF YOU ARE THE ONE WHO CAN HELP ME WITH THIS, BUT I WOULD LIKE AN INSERVICE ON THE PHASEAL FOR MY UNIT AS THERE STILL SEEMS TO BE SOME ISSUES WITH LEAKAGE THAT I THINK IS RELATED TO USER ERROR. I FEEL LIKE AN IN-SERVICE WILL HELP WITH THE ISSUES WE ARE EXPERIENCING. LET ME KNOW IF YOU CAN HELP ME WITH THIS. I APPRECIATE YOU! PER FULL EMAIL: I WANTED TO SEND OUT THIS EDUCATION AGAIN TO HELP KEEP EVERYONE SAFE. I HAVE INCLUDED ALL RNS FOR SITUATIONAL AWARENESS AND MANY OF YOU ARE NOT CHEMOTHERAPY PROVIDERS YET BUT ARE GOING THROUGH THE ONCOLOGY TIPS PROGRAM SO IT WILL BE GOOD INFORMATION FOR THE FUTURE. SITUATION: WE HAVE EXPERIENCED A FEW ADDITIONAL CHEMOTHERAPY DISCONNECTIONS AND SPILLS ON OUR UNIT INVOLVING PHASEAL CONNECTORS SINCE OUR PREVIOUS EDUCATION WAS SHARED. BACKGROUND: OVER THE PAST YEAR, THERE HAVE BEEN MULTIPLE DOCUMENTED CHEMOTHERAPY SPILLS RELATED TO PHASEAL CONNECTOR USE. EDUCATION WAS PREVIOUSLY PROVIDED AFTER CONSULTATION WITH BD PRODUCT EDUCATORS REGARDING PROPER CONNECTION TECHNIQUE. ASSESSMENT: REVIEW OF RECENT EVENTS CONTINUES TO SHOW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25085994 ↗
• MalfunctionMay 5, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD INJECTOR LOCKING N40-O HAD LEAKAGE AT THE LUER. COMPLAINT VIA EMAIL. I AM NOT SURE IF YOU ARE THE ONE WHO CAN HELP ME WITH THIS, BUT I WOULD LIKE AN INSERVICE ON THE PHASEAL FOR MY UNIT AS THERE STILL SEEMS TO BE SOME ISSUES WITH LEAKAGE THAT I THINK IS RELATED TO USER ERROR. I FEEL LIKE AN IN-SERVICE WILL HELP WITH THE ISSUES WE ARE EXPERIENCING. LET ME KNOW IF YOU CAN HELP ME WITH THIS. I APPRECIATE YOU! PER FULL EMAIL: I WANTED TO SEND OUT THIS EDUCATION AGAIN TO HELP KEEP EVERYONE SAFE. I HAVE INCLUDED ALL RNS FOR SITUATIONAL AWARENESS AND MANY OF YOU ARE NOT CHEMOTHERAPY PROVIDERS YET BUT ARE GOING THROUGH THE ONCOLOGY TIPS PROGRAM SO IT WILL BE GOOD INFORMATION FOR THE FUTURE. SITUATION: WE HAVE EXPERIENCED A FEW ADDITIONAL CHEMOTHERAPY DISCONNECTIONS AND SPILLS ON OUR UNIT INVOLVING PHASEAL CONNECTORS SINCE OUR PREVIOUS EDUCATION WAS SHARED. BACKGROUND: OVER THE PAST YEAR, THERE HAVE BEEN MULTIPLE DOCUMENTED CHEMOTHERAPY SPILLS RELATED TO PHASEAL CONNECTOR USE. EDUCATION WAS PREVIOUSLY PROVIDED AFTER CONSULTATION WITH BD PRODUCT EDUCATORS REGARDING PROPER CONNECTION TECHNIQUE. ASSESSMENT: REVIEW OF RECENT EVENTS CONTINUES TO SHOW THAT DISCONNECTIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25085993 ↗
• MalfunctionMay 5, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD INJECTOR LOCKING N40-O HAD LEAKAGE AT THE LUER. COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED I AM NOT SURE IF YOU ARE THE ONE WHO CAN HELP ME WITH THIS, BUT I WOULD LIKE AN INSERVICE ON THE PHASEAL FOR MY UNIT AS THERE STILL SEEMS TO BE SOME ISSUES WITH LEAKAGE THAT I THINK IS RELATED TO USER ERROR. I FEEL LIKE AN IN-SERVICE WILL HELP WITH THE ISSUES WE ARE EXPERIENCING. LET ME KNOW IF YOU CAN HELP ME WITH THIS. I APPRECIATE YOU! PER FULL EMAIL: I WANTED TO SEND OUT THIS EDUCATION AGAIN TO HELP KEEP EVERYONE SAFE. I HAVE INCLUDED ALL RNS FOR SITUATIONAL AWARENESS AND MANY OF YOU ARE NOT CHEMOTHERAPY PROVIDERS YET BUT ARE GOING THROUGH THE ONCOLOGY TIPS PROGRAM SO IT WILL BE GOOD INFORMATION FOR THE FUTURE. SITUATION: WE HAVE EXPERIENCED A FEW ADDITIONAL CHEMOTHERAPY DISCONNECTIONS AND SPILLS ON OUR UNIT INVOLVING PHASEAL CONNECTORS SINCE OUR PREVIOUS EDUCATION WAS SHARED. BACKGROUND: OVER THE PAST YEAR, THERE HAVE BEEN MULTIPLE DOCUMENTED CHEMOTHERAPY SPILLS RELATED TO PHASEAL CONNECTOR USE. EDUCATION WAS PREVIOUSLY PROVIDED AFTER CONSULTATION WITH BD PRODUCT EDUCATORS REGARDING PROPER CONNECTION TECHNIQUE. ASSESSMENT: REVIEW OF RECENT EVENTS CONTINUES TO SHOW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25085987 ↗
• MalfunctionApr 15, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD CONNECTOR C35-O HAD LEAKAGE AT THE LUER, THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 515070 AND 515056 BATCH # UNKNOWN COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED I AM NOT SURE IF YOU ARE THE ONE WHO CAN HELP ME WITH THIS, BUT I WOULD LIKE AN INSERVICE ON THE PHASEAL FOR MY UNIT AS THERE STILL SEEMS TO BE SOME ISSUES WITH LEAKAGE THAT I THINK IS RELATED TO USER ERROR. I FEEL LIKE AN IN-SERVICE WILL HELP WITH THE ISSUES WE ARE EXPERIENCING. LET ME KNOW IF YOU CAN HELP ME WITH THIS. I APPRECIATE YOU! PER FULL EMAIL: I WANTED TO SEND OUT THIS EDUCATION AGAIN TO HELP KEEP EVERYONE SAFE. I HAVE INCLUDED ALL RNS FOR SITUATIONAL AWARENESS AND MANY OF YOU ARE NOT CHEMOTHERAPY PROVIDERS YET BUT ARE GOING THROUGH THE ONCOLOGY TIPS PROGRAM SO IT WILL BE GOOD INFORMATION FOR THE FUTURE. SITUATION: WE HAVE EXPERIENCED A FEW ADDITIONAL CHEMOTHERAPY DISCONNECTIONS AND SPILLS ON OUR UNIT INVOLVING PHASEAL CONNECTORS SINCE OUR PREVIOUS EDUCATION WAS SHARED. BACKGROUND: OVER THE PAST YEAR, THERE HAVE BEEN MULTIPLE DOCUMENTED CHEMOTHERAPY SPILLS RELATED TO PHASEAL CONNECTOR USE. EDUCATION WAS PREVIOUSLY PROVIDED AFTER CONSULTATION WITH BD PRODUCT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24884393 ↗
• MalfunctionApr 15, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD INJECTOR LOCKING N40-O HAD LEAKAGE AT THE LUER, THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 515070 AND 515056 BATCH # UNKNOWN. COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED I AM NOT SURE IF YOU ARE THE ONE WHO CAN HELP ME WITH THIS, BUT I WOULD LIKE AN INSERVICE ON THE PHASEAL FOR MY UNIT AS THERE STILL SEEMS TO BE SOME ISSUES WITH LEAKAGE THAT I THINK IS RELATED TO USER ERROR. I FEEL LIKE AN IN-SERVICE WILL HELP WITH THE ISSUES WE ARE EXPERIENCING. LET ME KNOW IF YOU CAN HELP ME WITH THIS. I APPRECIATE YOU! PER FULL EMAIL: I WANTED TO SEND OUT THIS EDUCATION AGAIN TO HELP KEEP EVERYONE SAFE. I HAVE INCLUDED ALL RNS FOR SITUATIONAL AWARENESS AND MANY OF YOU ARE NOT CHEMOTHERAPY PROVIDERS YET BUT ARE GOING THROUGH THE ONCOLOGY TIPS PROGRAM SO IT WILL BE GOOD INFORMATION FOR THE FUTURE. SITUATION: WE HAVE EXPERIENCED A FEW ADDITIONAL CHEMOTHERAPY DISCONNECTIONS AND SPILLS ON OUR UNIT INVOLVING PHASEAL CONNECTORS SINCE OUR PREVIOUS EDUCATION WAS SHARED. BACKGROUND: OVER THE PAST YEAR, THERE HAVE BEEN MULTIPLE DOCUMENTED CHEMOTHERAPY SPILLS RELATED TO PHASEAL CONNECTOR USE. EDUCATION WAS PREVIOUSLY PROVIDED AFTER CONSULTATION WITH BD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24884391 ↗
• MalfunctionApr 3, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD CONNECTOR C35-O HAD LEAKAGE AT THE LUER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 515056, 515070, BATCH#: UNKNOWN. COMPLAINT VIA EMAIL. WE ARE EXPERIENCING ISSUES WITH THE BD PHASEAL OPTIMA INJECTOR N40 0 AND THE BD PHASEAL OPTIMA INFUSION CONNECTOR C35 0 LEAKING AT THE CONNECTION SITE WITH IV TUBING. (B D515056 AND B D515070) IS THIS A PREVIOUSLY REPORTED ISSUE? IS THIS A KNOWN ISSUE WITH A SOLUTION? SHOULD WE SEQUESTER AND SEND BACK THE AFFECTED LOTS?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24783841 ↗
• MalfunctionMar 19, 2026Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24644073 ↗
• MalfunctionMar 12, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD CONNECTOR C35-O HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING AT THE CONNECTION POINT DURING AZACITIDINE ADMINISTRATION. WHERE SOME OF THE DRUG LEAKING OUT OF THE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24587183 ↗
• MalfunctionMar 9, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE BD CONNECTOR C35-O HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EXTERNAL REF # (B)(4). MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN IT WAS REPORTED THAT CLINICIAN ENCOUNTERED LEAKAGE OF NON-HAZARDOUS DRUGS WHILE USING THE BD PHASEAL¿ OPTIMA CONNECTOR (C35-O) FOR PREPARING PARENTERAL DRUGS. VERBATIM: CLINICIAN EXPERIENCED: BD PHASEAL OPTIMA CONNECTOR LUER LOCK LEAKAGE DID NOT RESULT IN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24553570 ↗
• MalfunctionFeb 13, 2026Disconnection; Leak/Splash

  IT WAS REPORTED THAT THE BD CONNECTOR C35-O HAD A DISCONNECTION AT THE LUER LOCK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: CUSTOMER STATES THAT DURING A HOME INFUSION THE CONNECTOR "BLEW OFF OF THE EXTENSION SET" SEEMINGLY FROM A BUILD UP OF PRESSURE. A CLAMP WAS IN PLACE, AND WHILE STILL CONNECTED TO THE INJECTOR, THE CONNECTOR BLEW OFF THE TUBING WITH FORCE THAT CAUSED THE CLAMP TO OPEN, AND THE TUBING SWING UP AND HIT THE PATIENT IN THE FACE. THIS RESULTED IN A CHEMO SPILL AS THE FLUID PATHWAY WAS STILL OPEN AND THE PATIENT DID NOT RECEIVE THEIR ENTIRE DOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24338095 ↗
• MalfunctionJan 30, 2026Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24228785 ↗