BD PhaSeal 515004Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00382905150043), received between Nov 1, 2017 and Dec 30, 2025 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (11 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 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23922445 ↗
• MalfunctionApr 30, 2025Connection Problem; Connection Problem

  INJECTOR WAS DISCONNECTED FRÅN THE HOSE AND CYTOSTATICS HAVE LEAK. HAD HAPPENS COUPLE OF TIMES BEFORE. DURING USE ADDITIONAL INFORMATION WAS PATIENT OR USER HARMED? IF YES, PLEASE EXPLAIN: NO PLEASE PROVIDE THE BATCH# INFORMATION FOR ANOTHER REPORTED INCIDENT (HAD HAPPENS COUPLE OF TIMES BEFORE.). JUST INFO FROM NURSES. NO SAMPLES SAVED PLEASE PROVIDE THE DATE OF EVENT OF ANOTHER REPORTED INCIDENT (HAD HAPPENS COUPLE OF TIMES BEFORE.) IS THIS OCCURRED SINGLE PATIENT OR DIFFERENT PATIENT: NO DATES AVAILABLE PLEASE CLARIFY EXACTLY WHERE LEAK OCCURRED? SEE SFDC COMPLAIN PLEASE VERIFY DID YOU USED THE INFUSION CLAMP TO SECURE THE CONNECTION OF THE INJECTOR AND CONNECTOR. UNKNOWN WAS THERE ANY BREAKAGE/DAMAGE IN THE INJECTOR/CONNECTOR? UNKNOWN PLEASE CONFIRM, WAS THE INJECTOR ENGAGED WITH A MATING CONNECTOR WHEN THE PRESSURE WAS APPLIED TO THE SYRINGE? UNKNOWN, HAVE YOU ENSURED, THE INJECTOR WAS CONNECTED PROPERLY? WERE THERE ANY CONNECTION ISSUES? (LOOSE OR TIGHT) UNKNOWN BOTH INJECTOR AND CONNECTOR WERE DISCONNECTED FROM TUBING? OR INJECTOR DISCONNECTOR FROM CONNECTOR? UNKNOWN KINDLY PROVIDE THE CONNECTOR MATERIAL# AND BATCH#. PLEASE SEE SFDC WAS THERE ANY INFECTION OBSERVED FOLLOWING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934184 ↗
• MalfunctionApr 30, 2025Connection Problem; Connection Problem

  INJECTOR WAS DISCONNECTED FRÅN THE HOSE AND CYTOSTATICS HAVE LEAK. HAD HAPPENS COUPLE OF TIMES BEFORE. DURING USE ADDITIONAL INFORMATION: WAS PATIENT OR USER HARMED? IF YES, PLEASE EXPLAIN: NO. PLEASE PROVIDE THE BATCH# INFORMATION FOR ANOTHER REPORTED INCIDENT (HAD HAPPENS COUPLE OF TIMES BEFORE.). JUST INFO FROM NURSES. NO SAMPLES SAVED. PLEASE PROVIDE THE DATE OF EVENT OF ANOTHER REPORTED INCIDENT (HAD HAPPENS COUPLE OF TIMES BEFORE.) IS THIS OCCURRED SINGLE PATIENT OR DIFFERENT PATIENT: NO DATES AVAILABLE PLEASE CLARIFY EXACTLY WHERE LEAK OCCURRED? SEE SFDC COMPLAIN. PLEASE VERIFY DID YOU USED THE INFUSION CLAMP TO SECURE THE CONNECTION OF THE INJECTOR AND CONNECTOR. UNKNOWN. WAS THERE ANY BREAKAGE/DAMAGE IN THE INJECTOR/CONNECTOR? UNKNOWN. PLEASE CONFIRM, WAS THE INJECTOR ENGAGED WITH A MATING CONNECTOR WHEN THE PRESSURE WAS APPLIED TO THE SYRINGE? UNKNOWN . HAVE YOU ENSURED, THE INJECTOR WAS CONNECTED PROPERLY? WERE THERE ANY CONNECTION ISSUES? (LOOSE OR TIGHT) UNKNOWN. BOTH INJECTOR AND CONNECTOR WERE DISCONNECTED FROM TUBING? OR INJECTOR DISCONNECTOR FROM CONNECTOR? UNKNOWN. KINDLY PROVIDE THE CONNECTOR MATERIAL# AND BATCH#. PLEASE SEE SFDC. WAS THERE ANY INFECTION OBSERVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934172 ↗
• MalfunctionApr 17, 2025Connection Problem; Connection Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21856168 ↗
• MalfunctionOct 19, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ INJECTOR LUER LOCK N35C LEAKED LIQUID THROUGH THE MEMBRANE INTO THE AIR FILTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "WHEN THE ANTIBIOTIC HAS BEEN MIXED AND THE LIQUID IS TO BE DRAWN INTO THE SYRINGE, AND YOU ADJUST AND SPRAY SOME AIR BACK INTO THE BOTTLE, LIQUID LEAKS INTO THE AIR FILTER PART, IE THE BUBBLE IS FILLED WITH ANTIBIOTICS. THIS HAS HAPPENED REPEATEDLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12658025 ↗
• MalfunctionOct 14, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT INJECTOR LUER LOCK N35C LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN THE ANTIBIOTIC HAS BEEN MIXED AND THE LIQUID IS TO BE DRAWN INTO THE SYRINGE, AND YOU ADJUST AND SPRAY SOME AIR BACK INTO THE BOTTLE, LIQUID LEAKS INTO THE AIR FILTER PART."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12634648 ↗
• MalfunctionOct 9, 2020Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD PHASEAL¿ INJECTOR LUER LOCK N35C EXPERIENCED NEEDLE EXPOSURE -DEFECTIVE INJECTOR DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER PREPARATION WHEN THE NURSE REMOVED THE INJECTOR FROM THE PROTECTOR, THE NEEDLE WAS STILL OUT AND THE NURSE STUCK HERSELF ON THE NEEDLE. THE INJECTOR HAD NOT BEEN IN CONTACT WITH ANY PATIENT BUT ONLY WITH MEDICATION. ADDITIONAL INFORMATION: TODAY I RECEIVED RESPONSE FROM THE SALES REPRESENTATIVE, IT IS NOT POSSIBLE TO OBTAIN THE LOT NUMBER FOR THIS COMPLAINT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10655612 ↗
• MalfunctionJun 30, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THE INJECTOR LUER LOCK N35C EXPERIENCED NEEDLE EXPOSURE - DEFECTIVE INJECTOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER AND TRANSLATED FROM (B)(6) TO ENGLISH: "THE THREE-WAY CONNECTA WITH Q-SYTE LEAKS / TEARS RESULTING IN BLOOD LOSS OF THE PATIENT." DEVICE SAFETY MECHANISM FAILED TO SECURE NEEDLE WHICH CAN RESULT IN AN EXPOSED NEEDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10216219 ↗
• MalfunctionJun 29, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD PHASEAL¿ INJECTOR LUER LOCK N35C HAD FOREIGN MATTER IN THE DRUG VIAL. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RUBBER PARTICLE IN DRUG VIAL, CANNOT BE IDENTIFIED IF P50 OR N35C.

  Patient problems: No Patient Involvement

  MAUDE report 10209790 ↗
• MalfunctionApr 27, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD PHASEAL¿ INJECTOR LUER LOCK N35C HAD FOREIGN MATTER ON THE PLUNGER. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER WAS PREPARING MABTHERA MEDICATION FOR A PATIENT AT THE INFUSIONPOLICLINIC. THE DRUG WAS WITHDRAWN FROM A GLASS BOTTLE WITH A FILTER TO THE SYRINGE, BD PLASTIPAK 50 ML. THE SYRINGE WAS ATTACHED TO BD PHASEAL INJECTOR. AFTER TAKING IN 2 ML OF THE DRUG INTO THE SYRINGE, THE CUSTOMER NOTICED A PARTLY ATTACHED PINK PAPER OR PLASTIC LIKE CLOT ON THE PLUNGER OF THE SYRINGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10002339 ↗
• MalfunctionApr 9, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHEN THE BD PHASEAL¿ INJECTOR LUER LOCK N35C WAS CONNECTED TO THE FLUSH SYRINGE, THE SYRINGE WAS "NOT POSSIBLE" TO PUSH DOWN DURING USE. AS A RESULT, THE PHASEAL LEAKED "CYTOSTATICS" AND HAD TO BE REMOVED, WHILE THE FLUSH SYRINGE WAS CONNECTED DIRECTLY TO THE PATIENT'S IC-ACCESS. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN THE PHASEAL INJECTOR (N31) WAS CONNECTED TO A 20 ML. FLUSH SYRINGES, IT HAS IN MORE THAN ONE CASE BEING A PROBLEM, THAT IT IS NOT POSSIBLE TO PUSH THE FLUSH SYRINGES DOWN. THAT MAKES IT NESSECARY FOR THE STAFF TO TAKE THE PHASEAL PART OFF, AND CONNECT THE FLUSH SYRINGES DIRECTLY TO THE PATIENTS IC-ACESS." "THE STAFF AND THE PATIENT GET EXPOSED TO CYTOSTATICS".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9945618 ↗
• MalfunctionMar 24, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE CAP ON THE BD PHASEAL¿ INJECTOR LUER LOCK N35C WAS MISSING BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CAP ON THE INJECTOR WAS MISSING."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9873836 ↗
• MalfunctionMar 10, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PREPARATION CORING OCCURRED WITH A BD PHASEAL¿ INJECTOR LUER LOCK N35C. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE THAT MIXED THE ANTIBIOTIC SAW AFTER PREPARATION A SMALL PIECE (CORING) IN THE BOTTLE. SHE DIDN'T GIVE IT TO THE PATIENT. THEY USED PIPERACILLIN/TAZOBACTAM 4G/0,5G FROM FRESENIUS KABI. THEY DIDN'T SAVE THE BOTTLE AND WE DIDN'T GET SAMPLE. ONLY THAT IT WAS PREPARED WITH PHASEAL PROTECTOR AND INJECTOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9812663 ↗
• MalfunctionMar 10, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD PHASEAL¿ INJECTOR LUER LOCK N35C LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE COMPOUNDING UNIT ARE SENDING IN A COMPLAINT ABOUT A INJECTOR THAT ARE LEAKING AND YOU COULDN'T INJECT ANYTHING THROUGH IT. THEY COULDN'T SEE ANY DAMAGE ON IT AND THEY ARE SAYING IT LOOK GOOD AND OK. BUT IT LEAKED AND IT WHERE A KIND OF "VACUUM" AND YOU COULDN'T INJECT ANY CYTOTOXIC THROUGH THE INJECTOR. UPDATE THE 9TH OF MARCH: WHEN ADMINISTERING IM BLEOMYCIN, I NOTICE THAT THE SYRINGE IS LEAKING AND THE DRUG IN THE SYRINGE DRIPS TO THE SIDE. SO NO DRUG ENTERS THE PATIENT. I REMOVE THE SYRINGE TO SEE IF I CAN SEE ANY ERROR IN THE CONNECTION WITH PHA SEAL OR THE NEEDLE. I CHANGE THE CANNULA AND TRY AGAIN, I ADMINISTER ABOUT 1 ML OF THE DRUG AGAIN BUT WHEN I RELEASE A LITTLE FINGER THERE IS A BACK SUCK IN THE PHA SEAL CLUTCH AND THE SYRINGE GOES BACK TO THE ML WHERE I STARTED ON, SO NO DRUG HAS BEEN ADMINISTERED. - PATIENT WITH MDG TREATMENT, WHEN THE 5-FU SYRINGE IS TO BE SWITCHED ON, IT IS NOT POSSIBLE TO THREAD THE PHASEAL CONNECTION. A COLLEAGUE MAY REPLACE THE PHASEAL INJECTOR TO A NEW ONE IN THE CAPINET. - WHEN FLUOROURACIL SYRINGE IS T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9812309 ↗
• MalfunctionFeb 26, 2020Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT FLOW ISSUES OCCURRED DURING USE WITH A BD PHASEAL¿ INJECTOR LUER LOCK N35C. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE PHASEAL LUER LOCK CONNECTOR (C35) DID NOT ALLOW ANY INJECTION, AFTER CONNECTED TO THE INJECTOR. THE PHASEAL CONNECTOR AND THE PHASEAL INJECTOR WAS THEREFOR TAKEN OFF, AND THE INJECTION WAS GIVEN WITHOUT THE PROJECTION FROM THE PHASEAL DEVICES. UPDATE AFER ASKING IF THE DEFECT IS CLOG: "THE PROBLEM WAS, THAT THERE WAS NO ACCESS."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9759370 ↗
• MalfunctionFeb 17, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD PHASEAL¿ INJECTOR LUER LOCK N35C HAD FOREIGN MATTER ON IT. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THEY OPENED THE PACKING WITH INJECTORS THEY DISCOVERED THAT IS WAS STRANGE BLACK SPOTS ON IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9717813 ↗
• MalfunctionDec 11, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF INJECTOR LUER LOCK N35C EXPERIENCED LUER BREAKAGE -LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THEY ARE USING PHASEAL THE CUSTOMER TRIED TO GET THE INJECTOR FROM THE CONNECTOR BUT BROKE THE INJECTOR AND GOT THE NEED VISIBLE. THE NURSE ALSO GOT A NEEDLE STICK INJURY.

  Patient problems: Needle Stick/Puncture

  MAUDE report 9451766 ↗
• MalfunctionDec 3, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT LEAKAGE IS OCCURRING FROM THE MEMBRANE WITH A BD PHASEAL¿ INJECTOR LUER LOCK N35C. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNIVERSITY HOSPITAL HAVE BEEN USING PHASEAL FOR YEARS. NOW REALIZED, THAT WHEN USING N35 INJECTOR SMALL AMOUNTS IS ¿LEAKED¿ DRUG WITHOUT PUSHING SYRINGE. NOW THEY ARE WONDERING HOW MUCH OF DRUG IS MISSING FOR THE TREATMENT.THE DRUG USED WAS DACTINOMYCIN (1 ML). ADDITIONAL INFORMATION RECEIVED (B)(6) 2019: THE LEAK WAS FROM THE MEMBRANE OF THE INJECTOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9402996 ↗
• MalfunctionSep 23, 2019Leak/Splash; Leak/Splash

  IT HAS BEEN REPORTED THAT THE INJECTOR LUER LOCK N35C HAS BEEN FOUND WITH THE INJECTOR LOOSE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: ONCE AGAIN WE ENCOUNTER PROBLEMS WITH THE CONNECTION BETWEEN THE CONNECTOR AND INJECTOR IN THE DEPARTMENT WITH A DELIVERED CYTOSTATIC SYRINGE. THIS WAS 3 TIMES THE CASE FOR AN INTRATHECAL INJECTION ON PEDIATRIC ONCOLOGY THIS WEEK. IT IS DIFFICULT TO DETERMINE WHICH LOT NUMBER WAS USED. WE HAVE DIFFERENT LOT NUMBERS OF INJECTORS WITH CAP AND CONNECTORS IN STOCK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9106937 ↗
• MalfunctionApr 8, 2019Component Incompatible

  IT WAS REPORTED THAT BD¿ PHASEAL INJECTOR DOES NOT HOLD AT THE SYRINGE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE INJECTOR DOES NOT HOLD AT THE SYRINGE. WHEN PRESSURE IS APPLIED TO THE SYRINGE, THE INJECTOR ROTATES AND FALLS OFF. IT SEEMS THAT'S IT NOT COMPATIBLE WITH THE SYRINGES. THE PROBLEM WAS WITH MULTIPLE SPREADING BATCHES AND SYRINGE SIZES. THESE ARE ALL BD SYRINGES THAT WERE USED. THEREFORE, THE SYRINGES ARE TO BE EXCLUDED AS A PROBLEM. THE INJECTOR STOPS WHILE SCREWING, BUT NOT WHEN INJECTING INTO AN INFUSION BAG. (AS SOON AS PRESSURE COMES OUT OF THE SYRINGE).THEN HE FALLS OFF THE SYRINGE. UPDATE: IT WAS PUT ON CORRECTLY, TURNED ON AND AS SOON AS PRESSURE CAME OUT OF THE SYRINGE, THE INJECTOR LITERALLY LEAPT OUT. CONSIDER THAT THIS IS A CUSTOMER WHO HAS BEEN WORKING WITH THE INJECTOR FOR 13 YEARS..... SO DEFINITELY NO HANDLING PROBLEM. NAME OF DRUG: ENDOXAN, OXALIPLATIN, EPIRUBICIN, CARBOPLATIN, FLUORO URACIL, "GEMCITABINE", "GEMZAR", ALIMTA, KEYTRUDA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8493499 ↗
• MalfunctionApr 1, 2019Break; Mechanical Jam

  IT WAS REPORTED THAT A BD PHASEAL¿ INJECTOR LUER LOCK N35C WAS DAMAGED THE FOLLOWING WAS REPORTED, "THE CUSTOMER COULDN'T GET THE NEEDLE DOWN TO THE CONNECTOR. IT WAS HARD AND STUCKED. THE NEEDLE DIDN´T GO DOWN IN THE CONNECTOR."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8471663 ↗
• MalfunctionJan 28, 2019Leak/Splash

  IT WAS REPORTED THAT SIX BD PHASEALS HAD LEAKAGE WHEN PREPARING FOR COMPOUNDING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8282818 ↗
• MalfunctionDec 13, 2018Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE OF THE BD PHASEAL¿ INJECTOR LUER LOCK N35C, PHASEAL INJECTOR WAS RELEASED FROM THE INFUSION SET IN CONJUNCTION WITH CYTOSTATICS INJECTION. IT SHOULD HAVE BEEN TIGHTENED BUT SCREWED OFF AND FLUID FLOWED INTO THE PATIENT'S BED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8160814 ↗
• MalfunctionDec 12, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT "SMALL RUBBER PIECES" WERE SEEN IN THE BD PHASEAL¿ INJECTOR LUER LOCK N35C.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8156002 ↗
• MalfunctionSep 5, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BEFORE USE OF THE BD PHASEAL¿ INJECTOR LUER LOCK N35C, WHEN TAKING OUT OF THE PACKAGE THERE WAS WHITE PARTICLES ON BLUE PART OF THE INJECTOR. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7846775 ↗