BD PhaSeal 515304Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00382905153044), received between Jul 3, 2018 and Sep 28, 2023 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (11 reports).

2 FDA recall records name this device's identifier, 2 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 ↗

2. Jul 18, 2022Open, Classified

   Incorrect expiration date listed on the product labels. The expiration date listed on the product label is beyond the expiration date of the product.

   Z-1555-2022 · Root cause: Employee error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2023Break; Break

  IT WAS REPORTED THAT WHILE USING THE BD PHASEAL¿ Y-SITE CONNECTOR C80 BROKE. THE FOLLOWING WAS TRANSLATED FROM FRENCH TO ENGLISH: I HAVE TO ADMINISTER CHEMOTHERAPY IN A SYRINGE (VINCRISTRINE). THE DEVICE IS MADE WITH A CONNECTION MADE UP OF TWO BRANCHES, ONE FOR CHEMO AND ONE FOR INSERTING THE RINSING SYRINGES. SO I PUSH IN A FIRST RINSING SYRINGE, UNSCREW IT TO PUT IN A SECOND. THE SCREW THREAD BREAKS, AND THE RINSE FLOWS INTO THE COMPRESS BELOW. FOR THIS CHEMOTHERAPY, OUR PROTOCOL IS TO CARRY OUT A LARGE RINSE. THE CHILD COULD HAVE NOT RECEIVED HIS CHEMO CORRECTLY ADDITIONAL INFORMATION FROM CUSTOMER: NO, THE LUER CONNECTOR DID NOT BREAK OR DISCONNECT. THERE IS A CRACK ON THE THREAD OF THE Y SITE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17831392 ↗
• MalfunctionAug 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BD PHASEAL¿ Y-SITE CONNECTOR (C80) WAS LEAKING. THE FOLLOWING WAS RECEIVED BY THE INITITAL REPORTER: VERBATIM: CLINICIANS HAVE REPORTED THAT THE Y-SITE CONNECTOR ARE LEAKING - SEVERAL REPORTS MADE. THIS PRODUCT IS USED FOR BCG TREATMENT AND NEEDS TO BE A CLOSED SYSTEM. THE LEAKING IS NOTED AT THE BOTTOM (MALE LEUR-LOCK END) THAT ATTACHES CLOSEST TO THE CATHETER PHOTOS SUPPLIED AS THE ITEM WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17477324 ↗
• MalfunctionAug 4, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ Y-SITE CONNECTOR (C80) EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAD LEAKAGE INSIDE THE WHITE ADAPTER PIECE OF THE C80."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15164211 ↗
• MalfunctionOct 11, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 2 BD PHASEAL¿ Y-SITE CONNECTORS (C80) LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "WE GOT AN RECLAMATION ABOUT THE 515304 LOT:2103205 FROM THE LAST DELIVERY ON 2 EACHES, LIQUID DRIPS SIDEWAYS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12610589 ↗
• MalfunctionFeb 11, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ Y-SITE CONNECTOR C80 LEAKED FROM THE NOZZLE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "LEAKAGE AT THE RINCE NOZZLE, IT'S RECURRING"

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9694513 ↗
• MalfunctionJul 3, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THREE Y-SITE CONNECTORS C80 EXPERIENCED LEAKAGE AT THE Y SITE CONNECTOR DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 515304, BATCH NO.: UNKNOWN. Y-SITE LEAKED 3 SEPARATE TIMES ON BOTH ENDS OF CONNECTION. TAPED AND TIGHTENED BUT STILL LEAKED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8761051 ↗
• MalfunctionDec 5, 2018Disconnection; Leak/Splash

  IT WAS REPORTED THAT ARE LEAKAGE/DISCONNECTIONS BETWEEN THE BD PHASEAL¿ Y-SITE CONNECTOR C80, EXTENSION TUBING, AND CADD LEGACY PLUS 6500 DEVICES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8133782 ↗
• MalfunctionOct 11, 2018Leak/Splash

  IT WAS REPORTED THAT A CRACK IN THE BD PHASEAL¿ Y-SITE CONNECTOR C80 FLUSHING SITE CAUSED LEAKAGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7957493 ↗
• MalfunctionAug 20, 2018Crack; Leak/Splash

  IT WAS REPORTED THAT BD PHASEAL¿ Y-SITE CONNECTOR C80 CRACKED AND CAUSED A LEAK. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7798932 ↗
• MalfunctionAug 20, 2018Crack; Leak/Splash

  IT WAS REPORTED THAT BD PHASEAL¿ Y-SITE CONNECTOR C80 HAD A CRACK THAT LEAD TO LEAKAGE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7798910 ↗
• MalfunctionJul 18, 2018Crack

  IT WAS REPORTED THAT THE BD PHASEAL¿ Y-SITE CONNECTOR C80 HAD CRACKED CONNECTION. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7700717 ↗
• MalfunctionJul 18, 2018Fitting Problem

  IT WAS REPORTED THAT THE BD PHASEAL¿ Y-SITE CONNECTOR C80 HAD A DEFECTIVE FITTING. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7700646 ↗
• InjuryJul 12, 2018Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ Y-SITE CONNECTOR C80 LEAKED PRODUCT ONTO THE HEALTH CARE WORKER¿S FACE AT THE END OF THE CYTARABINE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7684067 ↗
• MalfunctionJul 12, 2018Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ Y-SITE CONNECTOR C80 HAD LEAKED. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7684065 ↗
• MalfunctionJul 11, 2018Leak/Splash

  IT WAS REPORTED THAT A BD PHASEAL¿ Y-SITE CONNECTOR C80 LEAKED BETWEEN THE INJECTOR AND CONNECTION THREADS. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7679014 ↗
• MalfunctionJul 3, 2018Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT A BD PHASEAL¿ Y-SITE CONNECTOR C80 WAS CRACKED AND LEAKED. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7658763 ↗