BD PhaSeal 515005Recalls & reported problems

Summary

The FDA's MAUDE database contains 128 adverse event reports that list this exact device (DI 30382905150051), received between Nov 8, 2017 and Oct 17, 2025 — classified as 128 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (27 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 128 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2025Contamination; Contamination

  EVENT DETAILS: THIS IS A COMPLAINT ABOUT P50J PROTECTOR CORING DURING USE. IT WAS REPORTED THAT ENDOXAN AND RITUXAN PREPARED. ASSEMBLY FIXTURE USED. COALING FRAGMENTS WERE OBSERVED IN THE VIAL. RITUXAN COLLECTION VIAL WAS REMOVED FROM P50 VIAL AS THE DRUG WAS COLLECTED. THE CORING FRAGMENTS WERE COLLECTED WHILE KEEPING A CLOSE EYE ON THE VIAL, BUT THE FRAGMENTS MOVED AND WERE DIFFICULT TO FIND. 2 RITUXAN VIALS ARE PRESENT. NOTE THAT A COMA FILTER AND CAPPED NEEDLE ARE ALSO ENCLOSED. LOT NUMBER OF THE INJECTOR IS 2501006.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23322186 ↗
• MalfunctionAug 25, 2025Contamination; Contamination

  IT WAS REPORTED THAT CORING WAS DISCOVERED DURING PEPCID PREPARATION. THE INJECTOR AND PROTECTOR HAD ALREADY BEEN CONNECTED. COLLECTION WAS INTERRUPTED AND ANOTHER VIAL WAS USED. JUDGING FROM THE COLOR, IT APPEARS TO BE ABRASION OF THE MEMBRANE. (LOT NUMBER FOR INJECTOR 515005 IS 2410010.)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22885220 ↗
• MalfunctionAug 7, 2025Contamination; Contamination

  IT IS REPORTED CORING. EVENT DESCRIPTION: THIS IS A COMPLAINT ABOUT BEVACIZUMAB CORING. IT WAS REPORTED THAT CORING OCCURRED INSIDE THE VIAL. CORING WAS DISCOVERED WHEN ATTEMPTING TO WITHDRAW THE DRUG (AFTER CONNECTING THE PROTECTOR AND INJECTOR). THE INJECTOR (515005) IS LOT2410008.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22739669 ↗
• MalfunctionAug 7, 2025Contamination; Contamination

  ADDITIONAL INFORMATION: THE PROTECTOR ATTACHED USING THE ASSEMBLY FIXTURE. THE PROTECTOR AND VIAL ARE CONNECTED, THEN THE PROTECTOR AND INJECTOR ARE CONNECTED. WHEN ATTEMPTING TO COLLECT THE DRUG, CORING IS NOTICED, AND COLLECTION IS INTERRUPTED. A DIFFERENT VIAL IS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22739663 ↗
• MalfunctionJul 28, 2025Leak/Splash; Leak/Splash

  IT IS REPORTED LEAKAGE. EVENT DESCRIPTION: THIS IS A COMPLAINT ABOUT LEAKING INJECTOR SECTION. LEAKAGE FROM THE INJECTOR PART WAS OBSERVED DURING PREPARATION. REQUESTED CONFIRMATION IF IT WAS A PRODUCT OR TECHNIQUE PROBLEM. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22631062 ↗
• MalfunctionJul 28, 2025Break; Break

  IT WAS REPORTED THAT THE NEEDLE POPPED OUT OF INJECTOR. EVENT DESCRIPTION: WHEN I TRIED TO REMOVE THE INJECTOR AFTER DOSING, THE NEEDLE POPPED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22629958 ↗
• MalfunctionJul 24, 2025Contamination; Contamination

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588334 ↗
• MalfunctionJul 24, 2025Contamination; Contamination

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587366 ↗
• MalfunctionJul 8, 2025Defective Component; Defective Component

  DESCRIPTION: CORING. EVENT DETAILS: IT WAS REPORTED THAT CORING DURING CIRCULISA PREPARATION. CONFIRMED IN VIAL AFTER CONNECTING PROTECTOR AND INJECTOR. THE SIZE SUGGESTS THAT IT WAS CAUSED BY PASSING THROUGH THE AIR NEEDLE OF THE PROTECTOR. INJECTOR LOT IS 2409011 AND PART NUMBER IS 515005.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22441301 ↗
• MalfunctionJul 8, 2025Defective Component; Defective Component

  DESCRIPTION: CORING. EVENT DETAILS: IT WAS REPORTED THAT CORE FORMED DURING PREPARATION OF ENDOXAN. CONFIRMED IN VIAL AFTER CONNECTING PROTECTOR AND INJECTOR. BASED ON SIZE, IT IS THOUGHT TO HAVE BEEN CAUSED BY THE PROTECTOR'S AIR NEEDLE PASSING THROUGH. THE LOT NUMBER OF THE INJECTOR IS 2409011 AND THE PART NUMBER IS 515005. CAN WE VERIFY IF THE PROTECTOR IS ASSEMBLED MANUALLY OR USING THE ASSEMBLY FIXTURE? THE PROTECTOR IS ASSEMBLED USING THE ASSEMBLY FIXTURE TO VERIFY, THE PARTICLE WAS OBSERVED BEFORE ENGAGING THE INJECTOR OR AFTER? CORING WAS DISCOVERED WHEN THE PROTECTOR AND INJECTOR WERE CONNECTED, AND THE DRUG WAS BEING COLLECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22440614 ↗
• MalfunctionJun 25, 2025Contamination; Contamination

  THIS IS A COMPLAINT ABOUT FOREIGN MATTER FOUND IN ABRAXANE BAG. EVENT DETAILS: IT WAS REPORTED THAT THREE VIALS OF ABRAXANE WERE PREPARED, THE LIQUID WAS COLLECTED FROM EACH VIAL, INFUSED INTO THE INFUSION BAG, AND BEFORE THE INFUSION BAG WAS HANDED OVER TO THE NURSE, THE PERSON IN CHARGE CHECKED THE BAG AND FOUND FOREIGN MATTER. WE WOULD LIKE TO REQUEST AN ANALYSIS OF THE SIZE OF THE CORE. (FOREIGN OBJECT MIXED INSIDE THE BAG) THE LOT NUMBER OF THE INJECTOR IS UNKNOWN. THE INCIDENT OCCURRED AFTER CONNECTING THE PROTECTOR AND INJECTOR. THE PRODUCT THAT WAS CONNECTED TO THE INFUSION BAG WAS 515309.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331781 ↗
• MalfunctionJun 25, 2025Contamination; Contamination

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329117 ↗
• MalfunctionJun 25, 2025Contamination; Contamination

  FOREIGN MATTER FOUND IN KEYTRUDA BAG. EVENT DETAILS: IT WAS REPORTED THAT TWO VIALS OF KEYTRUDA WERE PREPARED, THE LIQUID WAS COLLECTED FROM EACH VIAL AND INFUSED INTO THE INFUSION BAG. BEFORE THE INFUSION BAG WAS HANDED OVER TO THE NURSE, THE PERSON IN CHARGE CHECKED THE BAG AND FOUND FOREIGN MATTER. ONE PARTICLE WAS FOUND BY VISUAL INSPECTION. PLEASE ANALYZE THE SIZE OF THE CORE. (IT IS MIXED IN THE BAG.) THE LOT OF THE INJECTOR IS UNKNOWN. THE INCIDENT OCCURRED AFTER CONNECTING THE PROTECTOR AND INJECTOR. THE PRODUCT THAT WAS CONNECTED TO THE INFUSION BAG WAS 515309.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329103 ↗
• MalfunctionJun 25, 2025Contamination; Contamination

  FOREIGN MATTER IN BAG. EVENT DETAILS: IT WAS REPORTED THAT TWO VIALS OF 30 ML OF PACLITAXEL NK AND ONE VIAL OF 100 ML WERE PREPARED, AND AFTER COLLECTING THE LIQUID FROM EACH VIAL, IT WAS INFUSED INTO THE INFUSION BAG. BEFORE THE INFUSION BAG WAS HANDED OVER TO THE NURSE, THE PERSON IN CHARGE CHECKED THE BAG AND FOUND A FOREIGN OBJECT. WE REQUEST AN ANALYSIS OF THE SIZE OF THE FOREIGN OBJECT (PRESENT INSIDE THE BAG). THE LOT NUMBER OF THE INJECTOR IS UNKNOWN. THE INCIDENT OCCURRED AFTER CONNECTING THE PROTECTOR AND INJECTOR. THE CONNECTION WAS MADE APPROXIMATELY SIX TIMES. THE PRODUCT THAT WAS CONNECTED TO THE INFUSION BAG WAS 515309.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329091 ↗
• MalfunctionJun 25, 2025Contamination; Contamination

  IT WAS REPORTED FOREIGN OBJECT WAS FOUND. EVENT DETAILS: 30ML OF PACLITAXEL NK WAS PREPARED USING 4 VIALS, AND AFTER COLLECTING THE LIQUID FROM EACH VIAL, IT WAS INJECTED INTO AN INFUSION BAG. WHEN THE AUDITOR CHECKED THE INSIDE OF THE BAG BEFORE DISPENSING THE INFUSION BAG TO THE NURSE, A FOREIGN OBJECT WAS FOUND. WE WOULD LIKE YOU TO ANALYZE THE SIZE OF THE CORING. (CONTAMINATED INSIDE THE BAG) THE LOT OF THE INJECTOR IS UNKNOWN. THE INCIDENT OCCURRED AFTER THE PROTECTOR AND INJECTOR WERE CONNECTED. THE NUMBER OF CONNECTIONS WAS ABOUT 9 TIMES. 4 VIALS AND 1 INFUSION BAG WILL BE RETURNED. ADDITIONAL INFORMATION: 1: THIS IS THE SAME INJECTOR. 515005LOT IS UNKNOWN. 2: THE L CONNECTOR IS CONNECTED, AND THE COLLECTED MEDICATION IS INJECTED FROM THE L CONNECTOR INTO THE INFUSION BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22328009 ↗
• MalfunctionJun 25, 2025Contamination; Contamination

  FOREIGN OBJECT FOUND IN PACLITAXEL BAG. EVENT DETAILS: 11 VIALS OF 30ML PACLITAXEL NK WERE USED TO PREPARE THE DRUG, AND AFTER COLLECTING THE DRUG SOLUTION FROM EACH VIAL, IT WAS INJECTED INTO AN INFUSION BAG. WHEN CHECKED THE INSIDE OF THE BAG BEFORE DISPENSING THE INFUSION BAG, A FOREIGN OBJECT WAS FOUND. (PERHAPS BECAUSE SOME TIME HAS PASSED, THERE APPEARS TO BE CRYSTALLIZED DRUG FLOATING IN THE BAG, SEPARATE FROM THE CORING.) THE INJECTOR'S LOT IS UNKNOWN. THE INCIDENT OCCURRED AFTER THE PROTECTOR AND INJECTOR WERE CONNECTED. THE DRUG ADDED WAS PACLITAXEL. ADDITIONAL INFORMATION: THE PRODUCT THAT WAS CONNECTED TO THE INFUSION BAG WAS 515309. 1: PACLITAXEL IS A DRUG THAT IS SAID TO HAVE THE POTENTIAL TO CRYSTALLIZE (THIS IS ALSO WRITTEN IN THE PACKAGE INSERT), BUT THE PROBLEM HERE IS NOT THAT PART, BUT THE CORING THAT IS MIXED IN THE INFUSION BAG. IT IS MENTIONED TO PREVENT THE CRYSTALS FROM GETTING IN THE WAY AND PREVENTING THE CORING FROM BEING FOUND. 2: IT'S HIGHLY LIKELY THAT IT'S THE SAME INJECTOR. IN THAT CASE, IT MAY HAVE MADE 22 ROUND TRIPS. 515005 LOT IS UNKNOWN. 3: THE L CONNECTOR IS CONNECTED, AND THE COLLECTED DRUG IS INJECTED INTO THE INFUSION BAG FROM THE L CONNECT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22327650 ↗
• MalfunctionJun 25, 2025Contamination; Contamination

  FOREIGN OBJECT FOUND IN KEYTRUDA BAG. EVENT DETAILS: KEYTRUDA WAS PREPARED USING TWO VIALS, AND THE DRUG SOLUTION WAS COLLECTED FROM EACH VIAL AND INJECTED INTO AN INFUSION BAG. WHEN CHECKED THE BAG BEFORE DISPENSING THE INFUSION BAG TO THE NURSE, A VERY SMALL FOREIGN OBJECT WAS FOUND. WE WOULD LIKE AN ANALYSIS OF THE SIZE OF THE CORING. (CONTAMINATED IN THE BAG) THE INJECTOR'S LOT IS UNKNOWN. THE INCIDENT OCCURRED AFTER THE PROTECTOR AND INJECTOR WERE CONNECTED. ADDITIONAL INFORMATION: THE PRODUCT THAT WAS CONNECTED TO THE INFUSION BAG WAS 515309 1: THIS IS THE SAME INJECTOR. 515005 LOT IS UNKNOWN. 2: THE L CONNECTOR IS CONNECTED, AND THE COLLECTED MEDICATION IS INJECTED FROM THE L CONNECTOR INTO THE INFUSION BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22327624 ↗
• MalfunctionJun 25, 2025Contamination; Contamination

  IT IS REPORTED, FOREIGN OBJECT FOUND. EVENT DETAILS: KEYTRUDA WAS PREPARED USING 4 VIALS, AND THE DRUG SOLUTION WAS COLLECTED FROM EACH VIAL AND INJECTED INTO AN INFUSION BAG. WHEN CHECKED THE BAG BEFORE DISPENSING THE INFUSION BAG, MULTIPLE SMALL FOREIGN OBJECTS WERE FOUND. THE INJECTOR'S LOT IS UNKNOWN. THE INCIDENT OCCURRED AFTER THE PROTECTOR AND INJECTOR WERE CONNECTED. THE DRUG ADDED WAS KEYTRUDA. WE WOULD LIKE AN ANALYSIS OF THE SIZE OF THE CORING (CONTAMINATED IN THE BAG). ADDITIONAL INFORMATION: THE PRODUCT THAT WAS CONNECTED TO THE INFUSION BAG WAS 515309 CAN WE VERIFY- WAS IT THE SAME INJECTOR USED TO COLLECT FROM THE FOUR VIALS? THIS IS THE SAME INJECTOR. 515005 LOT IS UNKNOWN. WAS AN INFUSION ADAPTER CONNECTED TO THE IV BAG? THE L CONNECTOR IS CONNECTED, AND THE COLLECTED MEDICATION IS INJECTED FROM THE L CONNECTOR INTO THE INFUSION BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22327115 ↗
• MalfunctionJun 17, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT THE INJECTOR NEEDLE EXPOSED. THE INJECTOR NEEDLE IS EXPOSED AND WILL NOT RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22229212 ↗
• MalfunctionMay 27, 2025Defective Component; Defective Component

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087707 ↗
• MalfunctionMay 23, 2025Break; Break

  VERBATIM: THIS IS A COMPLAINT ABOUT THE NEEDLE IS EXPOSED DURING USE. IT WAS REPORTED THAT THE NEEDLE IS EXPOSED WHEN THE NURSE OPERATES IT. SALES REP RECEIVED THE ACTUAL PRODUCT, BUT THE NEEDLE IS EXPOSED. THEY THINK THE INJECTOR WAS BROKEN BY FORCING IT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078945 ↗
• MalfunctionMay 22, 2025Defective Component; Defective Component

  VERBATIM: THIS IS A COMPLAINT ABOUT CORING. IT WAS REPORTED THAT AFTER PREPARING NINE DOSES OF PACLITAXEL, CORE WAS OBSERVED WHEN THE DRUG WAS RETURNED TO THE BAG. THE CORE WAS SMALL, SUGGESTING THAT IT ORIGINATED FROM THE INJECTOR. ADDITIONAL INFORMATION: COULD YOU PLEASE CONFIRM WHETHER CORING OCCURRED AFTER THE INJECTOR INSTALLED? IF YES, COULD YOU PLEASE CONFIRM THE PRODUCT CODE AND LOT NUMBER OF THE INJECTOR? AFTER INSTALLING THE INJECTOR, CUSTOMER CONNECTED IT TO THE PROTECTOR AND CONFIRMED THE OCCURRENCE WHEN ATTEMPTING TO COLLECT THE LIQUID. THE LOT OF THE INJECTOR IS UNKNOWN. INJECTOR'S PRODUCT CODE IS 515005.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22069874 ↗
• MalfunctionMay 5, 2025Defective Device; Defective Device

  DESCRIPTION: ACCORDING TO THE CUSTOMER REPORT INFUSION SET OR INJECTOR PART FOUND TO BE DAMAGED DURING USE. ADDITIONAL INFORMATION: ANTICANCER DRUG USED -IRINOTECAN LOT FOR ZAT COMPONENT 2412141C. NURSE'S OPINION THE INJECTOR CONNECTION IS DAMAGED IT SEEMS THAT IT MAY HAVE BEEN CAUSED BY A MISHANDLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960958 ↗
• MalfunctionApr 16, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT CORING OCCURRED DURING PREPARATION OF ALKERAN. NO PATIENT HARM M12 ASSEMBLY FIXTURE WAS USED. A: OBSERVATION OF THE VIAL ONLY. A: AFTER THE INJECTOR WAS ASSEMBLED. A: INJECTOR LOT NUMBER 2408008 (PROBABLY) A: PROTECTOR LOT NUMBER (PROBABLY 2409102).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21849375 ↗
• MalfunctionJan 24, 2025Break; Break

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21229818 ↗