BD PhaSeal 515107Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00382905151071), received between Jan 9, 2018 and May 6, 2024 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (24 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19250215 ↗
• MalfunctionMar 5, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT PERFORATION TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18838150 ↗
• MalfunctionNov 6, 2023Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION: THE PATIENT WAS NOT HARMED AND THE PROTECTOR IS ATTACHED MANUALLY 2 THERE IS NO SAMPLE AVAILABLE. WHEN BLENDING ANTIBIOTICS PIP/TAZ ITS LEAKING BETWEEN THE VIAL OF THE BOTTLE AND THE PROTECTOR. WHEN DID THE INCIDENT OCCUR? - DURING USE. 1 THE PROTECTOR IS ATTACHED MANUALLY. 2 THERE IS NO SAMPLE AVAILABLE. I HAVE NOT GOT ANY ANSWER FROM THE CUSTOMER ABOUT THE LOTNUMBER THE PATIENT WAS NOT HARMED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18072862 ↗
• MalfunctionOct 11, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WE HAVE HAD/HAVE PROBLEMS WITH PROTECOR 51 PRODUCT NUMBER 515107. IT HAS OFTEN LEAKED LIQUID WHEN WE BOTTLED IT. ARE WE DOING WRONG OR PRODUCT WRONG?

  Patient problems: Insufficient Information

  MAUDE report 17911833 ↗
• MalfunctionAug 31, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING 2 OF THE BD PHASEAL¿ DRUG VIAL ACCESS DEVICE THERE WAS LEAKAGE. THE FOLLOWING WAS TRANSLATED FROM SWEDISH TO ENGLISH: LEAKEAGE FROM THE PROTECTOR LEAKAGE WHEN THEY MIXING ANTIBIOTICS. THE LEAKAGE WAS BETWEEN THE BOTTLE AND PROTECTOR. NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17666279 ↗
• MalfunctionAug 28, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD PHASEAL¿ DRUG VIAL ACCESS DEVICE LEAKAGE OCCURED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEKAGE FROM THE PROTECTOR AND THE VIAL THE INCIDENT OCCURRED DURING USE LEAKAGE BETWEEN THE VIAL AND PROTECTOR. THEY DON'T KNOW EXACTLY WHERE THE LEAKAGE OCCURRED. DIDN'T SAVE ANY PRODUCTS OR LOT NUMBER UNFORTUNATELY. 14AUG2023: FOLLOW UP SENT REQUESTING IF CUSTOMER ATTACHES PROTECTOR MANUALLY OR USING THE ASSEMBLY FIXTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17638647 ↗
• MalfunctionAug 14, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR P53 EXPERIENCED LEAKAGE AROUND THE MEMBRANE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN PREPARING ANTIBIOTIC PIPERACILLIN TAZOCIN WITH 32 MM SIZE MEMBRANE ITS LEAKING BETWEEN THE PROTECTOR AND MEMBRANE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17545665 ↗
• MalfunctionJul 27, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR P53EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE FROM PHASEAL PROTECTOR P53 WHEN USING PIP/TAZO SANDOZ 4/05G.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17410812 ↗
• MalfunctionNov 15, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT PROTECTOR P53 LEAKED ON 25 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE BETWEEN PROTECTOR AND VIAL. NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10841542 ↗
• MalfunctionOct 1, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTORS P53 EXPERIENCED LEAKAGE BETWEEN THE PROTECTOR AND VIAL DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE OF A CHEMO BETWEEN THE PROTECTOR AND THE VIAL OCCURRED. THE DRUG USED WAS CISPLATIN. ASSEMBLY FIXTURE WAS NOT USED. THERE WAS NO USE IN CLINICAL SETTINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10616388 ↗
• MalfunctionSep 9, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT PROTECTOR P53 LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS A REPORT ABOUT LEAKAGE OF CHEMO BETWEEN THE PROTECTOR AND THE VIAL. THE DRUG USED IS CISPLATIN."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10506515 ↗
• MalfunctionAug 4, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT 4 BD PHASEAL¿ PROTECTORS P53 EXPERIENCED LEAKAGE BETWEEN THE PROTECTOR AND VIAL DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE BETWEEN VIAL AND PROTECTOR (P53) WHEN PREPARING PIPERACILLIN/TAZOBACTAM. THIS HAS HAPPENED AT LEAST 4 TIMES. ALL FROM THE SAME LOT NO. NORMALLY THEY ARE USING P21 FOR SMALLER DRUG VIALS WITH DIAMETER 20MM, FROM FRESENIUS KABI. NOW THIS SIZE IS ON BACKORDER THEY HAVE INSTEAD RECEIVED LARGER VIALS WITH DIAMETER 32 MM AND THEREFORE NEED THE P53 PROTECTOR TO FIT. THESE VIALS ARE FROM GERMANY, WITH GERMAN LABELED VIALS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10365718 ↗
• MalfunctionJul 30, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 6 BD PHASEAL¿ PROTECTORS P53 EXPERIENCED LEAKAGE BETWEEN THE PROTECTOR AND VIAL DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE BETWEEN VIAL AND PROTECTOR (P53) WHEN PREPARING PIPERACILLIN/TAZOBACTAM. THIS HAS HAPPENED AT LEAST 6 TIMES. CUSTOMER COULD NOT TELL WHAT LOT NO IT IS. NORMALLY THEY ARE USING P21 FOR SMALLER DRUG VIALS WITH DIAMETER 20 MM. NOW THIS SIZE IS ON BACK ORDER THEY HAVE INSTEAD RECEIVED LARGER VIALS WITH DIAMETER 32 MM AND THEREFORE NEED THE P53 PROTECTOR TO FIT. THESE VIALS ARE FROM (B)(6), WITH (B)(6) LABELED VIALS. NO PHOTOS AVAILABLE AND THE USED PROTECTORS HAVE BEEN THROWN AWAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10348463 ↗
• MalfunctionJul 14, 2020Leak/Splash; Leak/Splash

  HOLD FOR MRD 07/21/20.IT WAS REPORTED THAT 15 BD PHASEAL¿ PROTECTORS P53 EXPERIENCED LEAKAGE BETWEEN THE PROTECTOR AND VIAL DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY HAD A LEAKAGE BETWEEN THE PROTECTOR AND THE VIAL. THE VIAL WAS ANTIBIOTICS. PROBABLY THE LEAKAGE PROBLEM COMES FROM THE VIALS NECK SIZE.

  Patient problems: No Patient Involvement

  MAUDE report 10269540 ↗
• MalfunctionJun 17, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 2 BD PHASEAL¿ PROTECTORS P53 EXPERIENCED LEAKAGE BETWEEN THE PROTECTOR AND VIAL DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE BETWEEN PROTECTOR AND VIAL WHEN THEY PREPARED ANTIBIOTICS. NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10165988 ↗
• MalfunctionApr 27, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 20 PROTECTORS P53 EXPERIENCED LEAKAGE BETWEEN THE PROTECTOR AND VIAL DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY HAD A LEAKAGE BETWEEN THE PROTECTOR AND THE VIAL. THE VIALS WERE ANTIBIOTICS. THEY ALSO HAD PROBLEMS THAT THE BALLOON DID NOT FILL WITH AIR. WE HAVE PRODUCTS FROM TWO LOT NUMBERS WITH THIS PROBLEM. BUT I THINK THE LEAKAGE PROBLEM COMES FROM THE VIALS NECK SIZE?

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10002791 ↗
• MalfunctionFeb 17, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PHASEAL PROTECTOR P53 IS LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHASEAL PROTECTOR IS LEAKING WHEN THEY USING IT ON PIP/TAZ WITH A THICK VIAL.".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9718045 ↗
• MalfunctionNov 4, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR P53 COULD NOT BE SECURED PROPERLY "WHEN USED FOR PIPERACILLIN / TAZOBACTAM", AND LEAKED DURING USE BETWEEN THE VIAL AND PROTECTOR WHEN "TILTED". THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKAGE WHEN USED FOR PIPERACILLIN / TAZOBACTAM". WHEN CUSTOMERS USE THE DRUG PIPERACILLIN / TAZOBACTAM FROM THE DRUG COMPANY, IT IS NOT POSSIBLE TO ATTACH THE PROTECTOR SO IT BECOMES TIGHT. SINCE THE VIAL IS MANUFACTURED IN A WAY THAT THE PROTECTOR CANNOT BE SECURED PROPERLY. THIS COMPLAINT IS THAT IT LEAKS FLUID BETWEEN THE VIAL AND THE PROTECTOR WHEN YOU TILT THE VIAL. THE CUSTOMER CANNOT SEE IF THE DRUG IS BETWEEN INJECTOR AND PROSTHETOR AS WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9272163 ↗
• MalfunctionOct 31, 2019Leak/Splash; Leak/Splash

  IT HAS BEEN REPORTED THAT THE PROTECTOR P53 HAS BEEN FOUND EXPERIENCING TWO OCCURRENCES OF LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: WHEN DRAWING CISPLATIN, DRUG LEAKED FROM BETWEEN THE PROTECTOR AND THE VIAL. AFTER LEAKAGE, CUSTOMER PRESSED P53 TO THE VIALS AND DREW DRUG SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9262532 ↗
• MalfunctionOct 23, 2019Leak/Splash; Leak/Splash

  IT HAS BEEN REPORTED THAT THE PROTECTOR P53 HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: LEAKAGE BETWEEN PROTECTOR AND VIAL. NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9225271 ↗
• MalfunctionOct 16, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PROTECTOR P53 EXPERIENCED LEAKAGE BETWEEN THE PROTECTOR AND VIAL DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE BETWEEN PROTECTOR AND VIAL. NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9197360 ↗
• MalfunctionSep 30, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE OF THE BD PHASEAL¿ PROTECTORS P53 THERE WAS LEAKAGE BETWEEN PROTECTOR AND VIAL. THIS OCCURRED ON 25 SEPARATE OCCASIONS BUT THE DATE/TIME IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE BETWEEN PROTECTOR AND VIAL. NO PATIENT INVOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9134841 ↗
• MalfunctionSep 24, 2019Leak/Splash; Leak/Splash

  IT HAS BEEN REPORTED THAT ONE PROTECTOR P53 HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: CISPLATIN(CHEMO) LEAKED FROM BETWEEN P53 AND THE VIAL. HCP COMMENTED THAT THE P53 FITS PROPERLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9112620 ↗
• MalfunctionAug 8, 2019Infusion or Flow Problem; Infusion or Flow Problem

  IT HAS BEEN REPORTED THAT ONE PROTECTOR P53 HAS BEEN FOUND EXPERIENCING FLOW ISSUES DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: WHEN DRAWING CISPLATIN, THE PROTECTOR WAS HARD DRAW. EVEN DREW THE DRUG, AIR GOT MIXED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8874446 ↗
• MalfunctionJul 3, 2019Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING USE OF THE BD PHASEAL¿ PROTECTORS P53 IT IS DIFFICULT TO INJECT AIR AND DRAW THE DRUG. THIS OCCURRED ON 10 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: CUSTOMER COMPLAINED WHEN USING P53, SOME LOT ARE HARD TO INJECT AIR AND DRAW DRUG.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8761102 ↗