BD PhaSeal 515117Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 00382905151170), received between Mar 9, 2018 and Nov 5, 2024 — classified as 1 injury, 70 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (30 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 71 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2024Leak/Splash; Leak/Splash

  THIS IS A COMPLAINT ABOUT LIQUID LEAKAGE DURING USE. IT WAS REPORTED THAT LIQUID LEAKED FROM A VIAL WITH A PROTECTOR ATTACHED TO IT. IT IS UNCLEAR WHETHER THE LEAKAGE IS FROM THE PROTECTOR OR THE VIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20611554 ↗
• MalfunctionSep 24, 2024Leak/Splash; Leak/Splash

  THIS IS A COMPLAINT ABOUT LEAKAGE OCCURRED WHEN PREPARING ABRAXANE.ACCORDING TO THE CUSTOMER REPORT TWO LEAKS OCCURRED WHEN PREPARING ABRAXANE. IN THE FIRST CASE, THE RUBBER STOPPER COLLAPSED WHEN THE PROTECTOR WAS ATTACHED, CAUSING A LEAK. IN THE SECOND CASE, BUBBLES FORMED BETWEEN THE VIAL AND THE PROTECTOR EVEN THOUGH IT WAS ATTACHED PROPERLY. IT SEEMED LIKE THE VIAL WAS LEAKING FROM A GAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20291264 ↗
• MalfunctionJul 23, 2024Leak/Splash; Leak/Splash

  THIS IS A COMPLAINT ABOUT LEAKAGE. IT WAS REPORTED THAT WHEN THE P55 WAS CONNECTED TO A VIAL, AND THE INJECTOR WAS CONNECTED, THE VIAL WAS TILTED TO MAKE ADJUSTMENTS, THE CHEMICAL SOLUTION LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19810102 ↗
• MalfunctionJul 1, 2024Contamination; Contamination

  IT WAS REPORTED THAT HUMAN HAIR-LIKE SUBSTANCE WAS FOUND INSIDE THE PROTECTOR. THERE IS SOMETHING THAT LOOKS LIKE HUMAN HAIR INSIDE THE BALLOON. (B)(6) ADDENDUM: ANTI-CANCER DRUG VIA IN PROTECTOR. A FOREIGN OBJECT WAS FOUND WHILE THE CABLE WAS CONNECTED. DRUG: CYRAMZA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643086 ↗
• MalfunctionJun 12, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT LEAKAGE WAS FOUND AFTER ATTACHING PROTECTOR DURING ENDOXAN PREPARATION. LIQUID WAS ADHERING TO THE PROTECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19518725 ↗
• MalfunctionJan 10, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  INCORRECT DEVICE REPORTED. SEE D AND H10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18489279 ↗
• MalfunctionOct 9, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR P55 WAS LEAKING. THE FOLLOWING WAS TRANSLATED FROM JAPANESE TO ENGLISH: THIS REPORT IS ABOUT LEAKAGE AFTER ATTACHING THE PROTECTOR. LEAKAGE WAS CONFIRMED AFTER CONNECTING THE ENDOXAN PROTECTOR (P55). AN INVESTIGATION WAS REQUESTED REGARDING THE LEAK POINT AND CONNECTION. THE PROTECTOR WAS ATTACHED MANUALLY. WE OBTAINED THE 2 SAMPLES AND THE SAMPLES WILL BE INVESTIGATED BY JFRL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17895943 ↗
• MalfunctionOct 4, 2023Defective Component; Defective Component

  IT WAS REPORTED WHILE USING BD PHASEAL¿ PROTECTOR P55 THE STOPPER DISLODGED INTO THE VIAL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE CUSTOMER REPORTED THAT THE PRODUCT DID NOT PENETRATE THE RUBBER STOPPER OF THE VIAL AND FELL INTO THE VIAL ALONG WITH THE RUBBER STOPPER. THE PRODUCT WAS PLACED IN THE ASSEMBLY FIXTURE AND AN ATTEMPT WAS MADE TO ATTACH IT TO THE VIAL, BUT IT DID NOT PENETRATE THE RUBBER STOPPER. WHEN THE ASSEMBLY FIXTURE HANDLE WAS PUSHED UP, THE VIAL'S RUBBER STOPPER FELL INTO THE VIAL. THE DRUG WAS PACLITAXEL. THE HOSPITAL WILL NOTIFY THE MANUFACTURER OF THE DRUG IF THERE WAS NO DEFECT WITH THE PROTECTOR. THE VIAL IS RETURNED WITH THE PROTECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17871135 ↗
• MalfunctionSep 20, 2023Contamination; Contamination

  IT WAS REPORTED THAT PLASTIC WAS FOUND ON THE TIP OF THE BD PHASEAL¿ PROTECTOR (P55) NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS REPORT IS ABOUT FM ON THE PLASTIC NEEDLE. A PLASTIC PIECE LIKE A CHIP WAS ON THE TIP OF THE PLASTIC NEEDLE. WHEN THE PRODUCT WAS ABOUT TO BE USED, A PLASTIC PIECE OF THE SAME MATERIAL WAS ON THE TIP OF THE PLASTIC NEEDLE. THERE HAD BEEN ONE SIMILAR CASE BEFORE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17785190 ↗
• MalfunctionAug 16, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT LEAKAGE OCCURRED BETWEEN THE BD PHASEAL¿ PROTECTOR (P55) AND VIAL WHILE PREPARING ENDOXAN. THIS OCCURRED WITH 2 PROTECTORS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS REPORT IS ABOUT LEAKAGE FROM THE PROTECTOR (P55). DURING PREPARATION OF ENDOXAN FOR INJECTION, LEAKAGE WAS OBSERVED FROM THE VIAL AFTER THE PROTECTOR WAS ATTACHED. THE EVENT WAS IDENTIFIED BY WATER DROPLETS ON THE SHEET. POSSIBLE BATCH NUMBER:2302125 OR 2301131".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17560538 ↗
• MalfunctionJul 7, 2023Crack; Crack

  IT WAS REPORTED THAT THE BD PHASEAL PROTECTOR P50J WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE CUSTOMER REPORTED THAT THE PROTECTOR CRACKED AND DAMAGED. WHEN ATTACHING THE PROTECTOR TO THE VIAL, DAMAGE TO THE PROTECTOR WAS OBSERVED .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17282821 ↗
• MalfunctionJun 28, 2023Break; Break

  IT WAS REPORTED THAT DURING USE WITH BD PHASEAL¿ PROTECTOR P55 THE SPIKE WAS DISCOVERED TO BE BROKEN WHEN ATTEMPTING TO ATTACH TO VIAL. THIS AFFECTED 13 DEVICES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS REPORT IS ABOUT PHASEAL PROTECTOR P55. DURING THE PREPARATION OF TREAKISYM, THE SPIKE WAS FOUND BROKEN WHEN ATTEMPTING TO ATTACH THE PRODUCT (P55) TO THE VIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17215953 ↗
• MalfunctionJun 26, 2023Contamination; Contamination

  IT WAS REPORTED THAT DURING USE WITH BD PHASEAL¿ PROTECTOR P55 CORING OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS REPORT IS ABOUT CORING THE RUBBER STOPPER FOR A VIAL. WHEN THE PROTECTOR WAS ATTACHED TO THE VIAL TO PREPARE ENDOXAN, CORING OCURRED. THE RUBBER PIECE WAS MIXED INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17202113 ↗
• MalfunctionJun 9, 2023Break; Break

  IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR (P55) NEEDLES WERE BENT AND BROKEN. THE FOLLOWING INFORMATION WAS TRANSLATED FROM JAPANESE TO ENGLISH: VERBATIM: THE CUSTOMER REPORTED THAT PLASTIC NEEDLES WERE BENT AND BROKEN BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17095628 ↗
• MalfunctionMay 17, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD PHASEAL¿ DRUG VIAL ACCESS DEVICE EXPERIENCED FLOW ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT A FLOW ISSUE OF THE PROTECTOR P55. ACCORDING TO THE CUSTOMER'S REPORT, DURING THE ANTICANCER AGENT (ABRAXANE) PREPARATION, THE HCP ATTEMPTED TO ADMINISTER SALINE BUT IT DID NOT FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16946416 ↗
• MalfunctionMay 6, 2023Break; Break

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD PHASEAL¿ PROTECTORS (P55) FROM 12 CASES OF PRODUCT HAD ISSUES WITH BROKEN/DAMAGED SPIKES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THE CUSTOMER'S VERBATIM REPORT IS AS FOLLOWS: BROKEN AIR VENT NEEDLES OF P55 (LOT#2204113) WERE FOUND IN 3 CASES WHEN THE PACKAGE WAS OPENED. PRODUCTS WITH SCRATCHES LIKE CLAW MARKS ON THE AIR VENT NEEDLES WERE FOUND IN 9 CASES. A TOTAL OF 12 DEFECTS WERE OBSERVED AND THE HCP DISCONTINUED ITS USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883185 ↗
• MalfunctionMay 5, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT TWO SILICON-LIKE FOREIGN MATTERS WERE OBSERVED IN THE EXPANSION CHAMBER OF BD PHASEAL¿ PROTECTOR (P55). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT FOREIGN MATTERS IN EXPANSION CHAMBER OF PROTECTOR. ACCORDING TO THE CUSTOMER'S REPORT, TWO SILICON-LIKE FOREIGN MATTERS WERE OBSERVED IN THE EXPANSION CHAMBER. IT MIGHT BE IN THE FILTER. THE HCP NOTICED IT IN USE BUT DECIDED IT WOULD NOT AFFECT PERFORMANCE AND CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16882375 ↗
• MalfunctionApr 18, 2023Break; Break

  IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR (P55) WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN THE PACKAGING WAS OPENED, THE PROTECTOR WAS FOUND BROKEN AND BROWN SPOTS WERE FOUND ON THE RIM OF THE PROTECTOR. UNABLE TO USE THE PRODUCT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16761560 ↗
• MalfunctionApr 13, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN, BROWN SPOTS WERE FOUND ON THE RIM OF THE BD PHASEAL¿ PROTECTOR (P55) BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN THE PACKAGING WAS OPENED, THE PROTECTOR WAS FOUND BROKEN AND BROWN SPOTS WERE FOUND ON THE RIM OF THE PROTECTOR. UNABLE TO USE THE PRODUCT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16740495 ↗
• MalfunctionMar 23, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD PHASEAL¿ PROTECTOR P55 LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A REPORT ABOUT CHEMO LEAKAGE WITH THE USE OF PROTECTOR. ACCORDING TO THE CUSTOMER'S REPORT, AFTER ATTACHING THE PROTECTOR TO THE VIAL OF ENDOXAN, LEAKAGE WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16607633 ↗
• MalfunctionMar 15, 2023Break; Break

  IT WAS REPORTED THAT 15 BD PHASEAL¿ PROTECTORS (P55) HAD ISSUES WITH BROKEN SPIKES FOUND BEFORE THE DRUG PREPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IN THE MEDICAL ONCOLOGY - BEFORE THE DRUG PREPARATION. IT WAS OBSERVED THAT THE SPIKE OF THE PROTECTOR WAS BROKEN WHEN THE VIALS WERE OPENED FOR CAPPING WITH THE PROTECTOR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16546831 ↗
• MalfunctionDec 6, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 2 BD PHASEAL¿ PROTECTORS (P55) EXPERIENCED FOREIGN MATTER WITHIN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT CORING. WHEN THE PROTECTOR (P55) WAS ATTACHED TO THE VIAL OF ENDOXAN USING ASSEMBLY FIXTURE, RUBBER PIECE-LIKE FM WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15928511 ↗
• MalfunctionOct 5, 2022Device Contamination with Chemical or Other Material; Material Protrusion/Extrusion; Device Contamination with Chemical or Other Material; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR (P55) HAD A SMALL, SHARP, PLASTIC PROTRUSION ON THE SPIKE THAT FELL INTO THE BOTTLE DURING THE PUNCTURE. THE SHARP MOLDING DEFECT EVENT OCCURRED WITH 30 PROTECTORS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: "THE PIERCING SPIKE HAS A SMALL PLASTIC TIP THAT ENTERS THE BOTTLE DURING PIERCING. CUSTOMER INFORMS US THAT WHEN USING ARI. 515117, IT WAS NOTICED THAT A SMALL PLASTIC TIP PROTRUDES FROM THE PUNCTURE SPIKE, WHICH GETS INTO THE BOTTLE WHEN PUNCTURING. AS A RESULT, ABOUT 100 PROTECTORS WERE OPENED, OF WHICH A GOOD 30 ARE AFFECTED. THE BATCH HAS NOW BEEN PUT TO ONE SIDE. IT SEEMS THAT THE PUNCTURE SPIKE WAS NOT DESIGNED PROPERLY DURING PRODUCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15544476 ↗
• MalfunctionApr 4, 2022Device Contamination with Chemical or Other Material; Material Twisted/Bent; Device Contamination with Chemical or Other Material; Material Twisted/Bent

  IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR (P55) WAS DAMAGED AND CAUSED CORING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECENTLY BEEN EXPERIENCING ISSUES WITH THE P14 CONNECTORS CAUSING CORING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13994520 ↗
• MalfunctionFeb 28, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BD PHASEAL¿ PROTECTOR P55 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHILE THE NURSE WAS PREPARING THE MEDICINE, THEY SAW HAIR IN THE PROJECTOR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13624751 ↗