BD PhaSeal 515305Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00382905153051), received between Nov 11, 2021 and Oct 17, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2022Leak/Splash; Material Separation; Mechanical Jam; Leak/Splash; Material Separation; Mechanical Jam

  IT WAS REPORTED THAT THE BD PHASEAL¿ L CONNECTOR C90 EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD A PROBLEM WITH A PHASEAL CONNECTOR (C90) WHERE THE VALVE WAS NOT WORKING AND THE PRODUCT LEAKED INTO THE TRANSPORT BAG. THIS INCIDENT HAS NOT HAPPENED AGAIN FOR THE MOMENT. PER FOLLOW UP RECEIVED FROM CUSTOMER: IT SEEMS THAT THE INTERNAL VALVE HAS FALLEN AT THE CONNECTOR AND THE PRODUCT WAS FLOWING THROUGH THE CONNECTOR. I ATTACH A PICTURE OF THE DEVICE WHERE WE CAN SEE THE ABSENCE OF THE VALVE. CLOSED TRANSFER SYSTEM CONNECTED TO AN ECOFLAC CONTAINING A CHEMOTHERAPY PRODUCT. THE SYSTEM HAS A LEAK AND THE PRODUCT LEAKS INTO THE TRANSPORT BAG. CLINICAL CONSEQUENCES AND CURRENT STATUS OF THE PATIENT OR PERSON INVOLVED: NO CONSEQUENCES ON THE PATIENT. LEAK IDENTIFIED BY THE NURSE UPON RECEIPT OF THE PRODUCT. ACTIONS TAKEN IN THE ESTABLISHMENT: DEVICE KEPT IN THE PHARMACY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620448 ↗
• MalfunctionNov 11, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER ATTACHING BD PHASEAL¿ L CONNECTOR C90 TO SALINE BAG FLUID LEAKAGE OCCURRED. THIS OCCURRED ON 6 OCCASIONS. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE FIND THAT THESE L-CONNECTORS WILL NOT ATTACH TIGHTLY TO BAGS OF 0.9% SALINE (VETIVEX) WHEREAS THEY PREVIOUSLY ATTACHED VERY WELL. WHEN PUSHED INTO THE SALINE BAG FLUID WILL LEAK AROUND THE EDGES, CAUSING POTENTIAL ESCAPE OF CYTOTOXIC AGENTS (IF THE BAG WERE TO CONTAIN ANY). THIS HAS HAPPENED WITH ALL THE C-90S WE HAVE USED IN THIS BATCH (AT LEAST 6). WE HAVE HAD TO DISCARD ALL C-90S USED (AND A NUMBER OF FLUID BAGS SINCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12801116 ↗