BD PhaSeal 515202Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00382905152023), received between Mar 9, 2018 and Dec 28, 2021 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (10 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2021Break; Break

  IT WAS REPORTED THAT BD LUER-LOCK CONNECTOR FOR USE WITH NEEDLE-FREE PORTS WAS DAMAGED, BUT STILL OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED LUER LOCK DISCONNECTION . "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13099660 ↗
• MalfunctionJun 29, 2021No Flow; No Flow

  IT WAS REPORTED THAT CONNECTOR LUER LOCK C45 HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT LUER LOCK CONNECTOR HAD TO BE CHANGED BEFORE PUMPS WOULD ALLOW THE INFUSION TO BEGIN ON TWO OCCASIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12089658 ↗
• MalfunctionJun 29, 2021No Flow; No Flow

  IT WAS REPORTED THAT CONNECTOR LUER LOCK C45 HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT LUER LOCK CONNECTOR HAD TO BE CHANGED BEFORE PUMPS WOULD ALLOW THE INFUSION TO BEGIN ON TWO OCCASIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12089635 ↗
• MalfunctionNov 12, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT CONNECTOR LUER LOCK C45 LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 515202; BATCH NO: UNKNOWN. IT WAS REPORTED THAT THE PHASEAL CONNECTOR LEAKING WHEN ADMINISTERING SQ CHEMOTHERAPY. QUESTION EMAIL INQUIRY FROM NURSE MANAGER: WE ARE HAVING AN ISSUE WITH THE PHASEAL CONNECTOR LEAKING WHEN ADMINISTERING SQ CHEMOTHERAPY. RESPONSE SPOKE WITH NURSE VIA PHONE. VERIFIED THAT THEY ARE USING THE CORRECT PHASEAL AND PHASEAL INJECTOR. PER THE PHASEAL CLINICAL PROCEDURES MANUAL, REVIEWED TECHNIQUE FOR CONNECTING THE PHASEAL CONNECTOR TO THE SYRINGE ASSEMBLY (PHARMACY SENDS PRE-FILLED CHEM SYRINGE WITH INJECTOR ATTACHED TO NURSES. NURSES THEN CONNECT THE NEEDLE AND CONNECTOR THE SYRINGE ASSEMBLY). VERIFIED THAT THEY ARE PERFORMING THIS TECHNIQUE CORRECTLY. ALSO SPOKE WITH PHARMACIST WHO PROVIDED THE PRODUCT CODES. HE DOES NOT HAVE THE LOT NUMBERS FOR THE PRODUCTS USED. INFORMED THAT THIS INFORMATION WILL BE SENT TO PRODUCT COMPLAINTS. EMAILED CASE TO PRODUCT COMPLAINTS. VERBATIM: PER CUSTOMER'S RESPONSE ON 11/02/2020, "HELLO, THE LEAK DID NOT OCCUR AT ANY CONNECTION. IT OCCURRED AT THE ACTUAL HEAD OF THE NEEDLE IF THAT MAKES SENSE? TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10832237 ↗
• MalfunctionJul 16, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD PHASEAL¿CONNECTOR LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN. THE FOLLOWING WAS REPORTED VIA EMAIL: I AM A NURSE PRACTICE SPECIALIST. WE USE THE PHASEAL CONNECTOR TO ADMINISTER HAZARDOUS MEDS, HOPING YOU CAN HELP WITH A QUESTION: WE RECENTLY HAD AN INCIDENT WHEN CHEMO BACKED UP AND POOLED INTO THE LUER LOCK PIECE AFTER THE PHASEAL WAS DISENGAGED FOR A BAG CHANGE. THE ORIGINAL BAG HAD BEEN CONNECTED FOR 24 HOURS. I UNDERSTAND THAT WHEN DISENGAGING THE PHASEAL WE SHOULD WAIT ~30 SECONDS AFTER PULLING BACK BEFORE FULLY DISENGAGING THE PHASEAL DEVICE TO PREVENT THE RISK OF LEAKING. PER SALES REP: THE NURSE DISCONNECTED HER CHEMO AFTER 24 HOURS AND NOTICED SOME CHEMO LEAKING OUT OF THE PHASEAL CONNECTOR. SHE REPORTED APPROXIMATELY 2 MLS. SHE HAD NO EXPOSURE AND NEITHER DID THE PATIENT. SHE DOES NOT HAVE ANY LOT NUMBERS. THE CONNECTOR WAS NOT USED FOR MORE THAN 10 PUNCTURES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10287130 ↗
• MalfunctionDec 27, 2019Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE CONNECTOR LUER LOCK C45 EXPERIENCED FLOW ISSUES WHEN USED FOR INFUSION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 515202, BATCH NO: UNKNOWN. EVENT DESCRIPTION: N35/C45 SEEMED TO BE CLOGGED WHEN STARTING INFUSION. THE DRUG FROM SECONDARY CHEMO BAG WAS NOT PULLING. SEEMED LIKE IT WAS JUST PULLING AIR. THEY CHANGED N35 & C45 AND EVERYTHING WORKED FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9527883 ↗
• MalfunctionOct 15, 2019Leak/Splash; Leak/Splash

  MATERIAL NO.: 515202. BATCH NO.: UNKNOWN. IT WAS REPORTED THAT DURING USE THE BD CONNECTOR LUER LOCK C45 CONNECTORS ARE COMING OFF OF THE INJECTORS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE HAVING SOME PROBLEMS WITH PATIENTS ON CONTINUOUS INFUSIONS WITH PHASEAL COMING DISCONNECTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9193158 ↗
• MalfunctionOct 4, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CONNECTOR LUER LOCK C45 EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 515202, BATCH NO.: UNKNOWN. PER EMAIL: LEAKING NOTED AT CONNECTION BETWEEN PHASEAL AND NEEDLE PHASEAL LUER LOCK CONNECTOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9157387 ↗
• MalfunctionSep 25, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CONNECTOR LUER LOCK C45 EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 515202, BATCH NO.: 1811107. PER EMAIL: PHASEAL CONNECTOR ATTACHED TO THE LOWER Y-SITE ON THE PRIMARY BD TUBING. INFUSING THROUGH THE PRIMARY LINE. DRIPPING OUT PHASEAL ONTO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9119575 ↗
• MalfunctionAug 16, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER INFUSION, THE CHEMO LINE AND EXTENSION TUBING WAS CLAMPED. WHEN DISENGAGING THE INJECTOR FROM THE CONNECTOR SALINE BEGAN TO LEAK WITH A BD CONNECTOR LUER LOCK C45. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE WAS "LEAKING OUT FROM WHERE THE NEEDLE PUNCTURES THROUGH THE MEMBRANE ON THE C45 ONTO THE FLOOR." PATIENT WAS RECEIVING A 24HR CHEMO. THE INFUSION HAD A N35 ON THE END OF THE CHEMO TUBING WHICH WAS CONNECTED ONTO A C45 ON THE PATIENT'S KVO LINE AT THE LOWEST PORT ON THE KVO LINE. WHEN THE INFUSION WAS DONE, THE RN CLAMPED TUBING ON THE CHEMO LINE, AND CLAMPED THE EXTENSION TUBING ON THE HUBER NEEDLE, THEN THE RN DISENGAGED THE INJECTOR FROM THE CONNECTOR AND WAITED A FEW SECONDS BEFORE COMPLETELY REMOVING THE INJECTOR FROM THE CONNECTOR. THE RN LEFT THE CONNECTOR ON AS SHE WOULD BE HANGING ANOTHER 24HR CHEMO INFUSION. WHILE GETTING THE NEXT CHEMO READY, THE PATIENT WAS STANDING UP AND I WAS IN THE ROOM THE WHOLE TIME FOR THE DISCONNECTION. I LOOKED DOWN AND DROPS OF SALINE FROM THE KVO LINE WERE LEAKING OUT FROM WHERE THE NEEDLE PUNCTURES THROUGH THE MEMBRANE ON THE C45 ONTO THE FLOOR. THE RN REMOVED THAT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8901516 ↗
• MalfunctionMay 17, 2019Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THERE WAS A FLOW ISSUE WHERE INJECTOR/CONNECTOR DID NO BACKPRIME INTO SECONDARY INFUSION WITH A BD CONNECTOR LUER LOCK C45. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 515202, BATCH NO. 1804105. IT WAS REPORTED THAT THE INJECTOR/CONNECTOR DID NOT ALLOW THE RN TO BE ABLE TO BACKPRIME NS INTO A SECONDARY INFUSION. "INTERESTINGLY ENOUGH¿ WE HAD ANOTHER PHASEAL ISSUE OVERNIGHT WHERE THE INJECTOR/CONNECTOR DID NOT ALLOW THE RN TO BE ABLE TO BACKPRIME NS INTO A SECONDARY INFUSION. THERE IS A SAFETY REPORT IN--- 254045. THE RN REMOVED AND REPLACED THE PHASEAL WITH NO SUCCESS. WHAT WAS CONCERNING WAS THAT SHE WAS ADVISED BY PHARMACY OVERNIGHT TO ¿SPIKE AND REPRIME YOURSELF¿¿ WHICH THE RN DID NOT DO AS IT IS NOT CONSISTENT WITH OUR SAFE HANDLING STANDARDS. ENDED UP USING THIS MORNING¿S DOSE AND IT WAS ABLE TO BE BACK-PRIMED.' CONNECTOR IS REF 515202, LOT IS 1804105.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8619911 ↗
• MalfunctionApr 10, 2019Leak/Splash

  IT WAS REPORTED THAT THE CONNECTOR LUER LOCK C45 EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 515202 BATCH NO: 1809105, 1711109. IT WAS REPORTED THAT DURING ADMINISTRATION OF VELCADE, 3-5 DROPS OF THE CHEMOTHERAPY DRUG LEAKED FROM THE NEEDLE/PHASEAL CONNECTION ONTO THE PATIENT. EVENT DESCRIPTION PER ATTACHED MEDWATCH REPORT STATES, "NURSE ADMINISTERING VELCADE SUBQ USING BD PHASEAL CLOSED SYSTEM DRUG TRANSFER DEVICE, 3-5 DROPS OF CHEMOTHERAPY MEDICATION LEAKED FROM THE NEEDLE-PHASEAL CONNECTION ONTO THE PATIENT. THIS IS NOT THE FIRST TIME THE PHASEAL HAS MALFUNCTIONED WHEN ADMINISTERING A MEDICATION SUBCUTANEOUSLY. CONNECTOR LUER LOCK WERE USED IN THIS EVENT, HOWEVER, THE EVENT WAS REPLICATED IN THE PAST WITH OTHER LOT NUMBERS. BD HAS BEEN NOTIFIED IN THE PAST OF THIS ISSUE."

  Patient problems: Chemical Exposure

  MAUDE report 8501186 ↗
• MalfunctionDec 26, 2018Leak/Splash

  IT WAS REPORTED THAT BD PHASEAL¿CONNECTOR LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8196497 ↗
• MalfunctionDec 19, 2018Leak/Splash

  IT WAS REPORTED THAT BD PHASEAL¿CONNECTOR LEAKED VAPORS OUT OF THE DEVICE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8180368 ↗
• MalfunctionOct 23, 2018Material Protrusion/Extrusion

  IT WAS REPORTED THAT IT WAS DIFFICULT TO DISENGAGE THE INJECTOR ON A BD PHASEAL¿CONNECTOR THIS CAUSED THE NEEDLE TO REMAIN EXPOSED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7996360 ↗
• MalfunctionJul 31, 2018Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL CONNECTOR LEAKED. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7736230 ↗
• MalfunctionMay 23, 2018Fluid/Blood Leak

  IT WAS REPORTED WITH THE USE OF THE BD PHASEAL¿CONNECTOR THERE WAS AN ISSUE WITH LEAKAGE. IT WAS STATED ¿UPON COMPLETION OF CHEMO INFUSION, THE CHEMO BAG AND INJECTOR WERE REMOVED. A SALINE SYRINGE WAS CONNECTED TO A CLAVE CONNECTION ON THE PATIENT TUBING. AT THE END OF THE FLUSH APPROXIMATELY 3-5 DROPS OF (PROBABLE) SALINE SPILLED OUT ONTO THE PAD UNDER THE CONNECTOR". THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7538245 ↗
• MalfunctionMay 23, 2018Fluid/Blood Leak

  IT WAS REPORTED WITH THE USE OF THE BD PHASEAL¿CONNECTOR THERE WAS AN ISSUE WITH LEAKAGE. IT WAS STATED ¿UPON COMPLETION OF CHEMO INFUSION, FLUSH BAG ATTACHED AT CLAVE SITE ON TUBING ABOVE PUMP CASSETTE AND INFUSED. A SECOND CHEMO WAS ATTACHED TO THE INFUSION TUBING BELOW THE PUMP CASSETTE ON THE CLAVE CONNECTOR CLOSEST TO THE PATIENT - TUBING WAS CLAMPED. WHEN THE INJECTOR WAS REMOVED FROM THE CONNECTOR (OF THE COMPLETED CHEMO), A FEW DOTS OF FLUID WERE NOTED ON THE PAD UNDER THE CONNECTOR THESE DOTS WERE PROBABLY SALINE FROM THE FLUSH". THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7538242 ↗
• MalfunctionMay 23, 2018Detachment Of Device Component; Fluid/Blood Leak

  IT WAS REPORTED WITH THE USE OF THE BD PHASEAL¿CONNECTOR THERE WAS AN ISSUE WITH A LEAKAGE. IT WAS STATED ¿WHEN THE PATIENT ATTEMPTED TO GET UP FROM THE BED, THE CHEMO LINE DISENGAGED CAUSING A LEAK OF LESS THAN 5CC ONTO THE FLOOR, AND ONE DROP ON THE PATIENT". THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7537697 ↗
• MalfunctionMar 9, 2018Device Operates Differently Than Expected; Difficult to Open or Close

  IT WAS REPORTED THAT THE CONNECTOR OF A BD PHASEAL¿CONNECTOR WAS NOT OPENING THE IV TUBING VALVE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7328379 ↗