BD PhaSeal 515302Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00382905153020), received between Aug 6, 2018 and Feb 12, 2025 — classified as 39 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (20 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2025Packaging Problem; Packaging Problem

  NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21366210 ↗
• MalfunctionDec 31, 2024Leak/Splash; Leak/Splash

  CAN YOU CONFIRM THE APPROXIMATE LOCATION OF THE LEAKAGE ON THE ADAPTER? -THE LEAKAGE WAS OBSERVED AT THE JUNCTION BETWEEN THE TRANSPARENT TUBING AND THE BODY OF THE ADAPTER, WHERE A WHITE ERGO CAN BE SEEN TO WHICH THE TUBING IS ATTACHED. CAN YOU CONFIRM THAT THE ADAPTER HAS SUFFERED ANY OBVIOUS DAMAGE? -THERE'S NO OBVIOUS DAMAGE TO THE ADAPTER! CAN YOU CONFIRM THAT YOU ARE ABLE TO PROVIDE OUR TEAM WITH AN IMAGE OR VIDEO OF THE LEAKAGE AS IT OCCURS? -WE'LL TRY TO SEND THIS TO YOU, BUT THERE'S NO GUARANTEE OF RESULTS! CAN YOU CONFIRM THAT THE SAME ADAPTER WAS USED FOR BOTH PREPARED BAGS? -YES, WE'VE USED THE SAME ADAPTERS ON OTHER PREPARATIONS WITHOUT NOTICING ANY LEAKAGE; FORTUNATELY! **NO ADDITIONAL INFORMATION RECEIVED

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

  MAUDE report 21048098 ↗
• MalfunctionNov 18, 2024Packaging Problem; Packaging Problem

  NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20710057 ↗
• MalfunctionNov 18, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD PHASEAL HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLACK STAIN IS OBSERVED ON THE PART AND OUTER PACKAGING IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20708335 ↗
• MalfunctionOct 25, 2024Break; Break

  IT WAS REPORTED THAT THE BD SECONDARY SET C61 HAD LUER LOCK BREAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SHORT DESCRIPTION A PIECE WAS CHIPPED FROM THE END OF THE TUBE (CONNECTION PART TO MAIN IV LINE) PHARMACIST NOTICED DURING USAGE, THAT A PIECE WAS CHIPPED FROM THE END OF THE TUBE (CONNECTION PART TO MAIN IV LINE). WHEN DID THE INCIDENT OCCUR? DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20539428 ↗
• MalfunctionJun 18, 2024Break; Defective Component; Break; Defective Component

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558650 ↗
• MalfunctionDec 21, 2023Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE BD PHASEAL PACKAGE SEAL WAS COMPROMISED, LEADING TO TUBING DAMAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "USER OPENED A NEW SET OF 515302 AND FOUND OUT THE TUBING IS DAMAGED." ADDITIONAL INFORMATION RECEIVED ON 12-DEC-2021: "JUST CONFIRMED WITH USER, THE TUBING WAS DAMAGED DUE TO THE SEAL. THE SEAL COMPRESSED ONTO THE TUBING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18380338 ↗
• MalfunctionDec 21, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL WAS LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I WOULD LIKE TO FILE A PRODUCT FEEDBACK - CHEMO DRIP LEAKING FROM THE TOP OF SECONDARY SET BATCH: 1024993 EXP: 05/2026. PHOTOS ATTACHED - WET INSIDE ZIPPER BAG. PRODUCT RETURNED BY DAYCARE ONCOLOGY NURSE - VISIBLE DROPLETS INSIDE ZIPPER BAG WITH THE PRODUCT. DAY NURSE CLAIMED IT WAS LEAKY FROM THE TOP OF SECONDARY SET. PHARMACY REDO A NEW PRODUCT FOR NURSE AND DISCARDED THE HAZARDOUS LEAKY PRODUCT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18373017 ↗
• MalfunctionOct 24, 2023Defective Component; Packaging Problem; Defective Component; Packaging Problem

  NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17999989 ↗
• MalfunctionSep 11, 2023Defective Component; Defective Component

  NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17726097 ↗
• MalfunctionAug 22, 2023Component Missing; Component Missing

  NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597394 ↗
• MalfunctionJul 27, 2023Component Missing; Component Missing

  IT WAS REPORTED WHILE USING BD SECONDARY SET C61 THE TUBING CLAMP WAS MISSING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEW SET OF C61 COMES WITHOUT CLAMP - MISSING COMPONENT. SAME BATCH OF ITEM REPORTED ANOTHER PIR ON 4 JULY 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17405117 ↗
• MalfunctionJun 13, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 5 OF THE BD PHASEAL¿ SECONDARY SET C61 EXPERIENCED BLOCKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SALINE IS NOT COMING OUT FROM THE SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17120754 ↗
• MalfunctionJun 13, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT 5 OF THE BD PHASEAL¿ SECONDARY SET C61 EXPERIENCED BLOCKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SALINE IS NOT COMING OUT FROM THE SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17120685 ↗
• MalfunctionMay 4, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD SECONDARY SET C61 LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CHEMOTHERAPY DRUG LEAKED OUT FROM THE TUBING AFTER CHEMOTHERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16872597 ↗
• MalfunctionDec 19, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ SECONDARY SET C61 LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE DURING INFUSION CAUSING SPILLAGE IN THE WARDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16006043 ↗
• MalfunctionOct 11, 2022Delivered as Unsterile Product; Unsealed Device Packaging; Material Split, Cut or Torn; Delivered as Unsterile Product; Unsealed Device Packaging; Material Split, Cut or Torn

  IT WAS REPORTED THAT 3 BD PHASEAL¿ SECONDARY SETS C61 HAD DAMAGED TUBING THAT WAS SLICED OPEN THROUGH THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "3 UNITS OF C61 WERE SLICED DUE TO PACKAGING ERROR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15580808 ↗
• MalfunctionMay 31, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD PHASEAL¿ SECONDARY SET C61 WAS LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING C62 - MORE INFORMATION REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8658420 ↗
• MalfunctionMay 22, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD PHASEAL¿ SECONDARY SET C61 LEAKED. THIS OCCURRED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE FROM C61 THEY HAVE NOTICED THE LEAKAGE AT PHARMACY RIGHT AFTER SYTOSTATIC PREPARATION. LEAKAGE COMES FROM TUBING (THE CONTACT PART TO SPIKE). THEY HAVE REALIZED SAME KIND OF PROBLEMS EARLIER THIS MONTH, BUT HAVEN¿T BEEN REPORTING THOSE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8632607 ↗
• MalfunctionMay 22, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT LEAKAGE OCCURRED WITH A BD PHASEAL¿ INFUSION SET (C61). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PHARMACIST INSERT THE SECONDARY LINE C61 INTO THE INFUSION BOTTLE AND CLAMP THE LINE AFTER PRIMING THE TUBING. DURING INSERTION OF CYTOTOXIC DRUG RITUXIMAB INTO THE INFUSION BOTTLE, THERE'S NO LEAKAGES OBSERVED. DURING ADMINISTRATION OF THE DRUG TO PATIENT, THE NURSE IN CHARGES NOTICE THERE'S LEAKAGES OCCURS AND THE INFUSION BOTTLE WAS THEN RETURN TO THE PHARMACY TO EXCHANGE A NEW SECONDARY SET TO AVOID WASTAGE OF THE DRUG. THE FAULTY SECONDARY SET WAS KEPT AND AVAILABLE TO CLARIFY FOR THE LEAKAGE BY THE PHARMACIST. THE LEAKAGES OCCURS DOES NOT HARM EITHER THE NURSE OR THE PATIENT. THE PHARMACIST AND NURSE ARE USING THE PRODUCT AND THERE¿S NOT PHYSICAL HARM TO THE USER OR PATIENT DUE TO THE LEAKAGE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8632307 ↗
• MalfunctionMay 14, 2019Leak/Splash

  IT WAS REPORTED THAT LEAKAGE OCCURRED WITH A BD PHASEAL¿ INFUSION SET (C61). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PHARMACIST INSERT THE SECONDARY LINE C61 INTO THE INFUSION BAG AND CLAMP THE LINE AFTER PRIMING THE TUBING. DURING INSERTION OF CYTOTOXIC DRUG ETOPOSIDE INTO THE INFUSION BAG, LEAKAGES OCCURS AT THE TUBING AREA AND THE PHARMACIST STOP THE INSERTION AND QUICKLY CHANGE THE SECONDARY LINE C61 TO AVOID FURTHER WASTAGE OF THE DRUG. UPDATED INFO: THERE¿S NOT PHYSICAL HARM TO THE USER OR PATIENTS DUE TO THE LEAKAGES OCCUR."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8608011 ↗
• MalfunctionMay 9, 2019Fluid/Blood Leak

  IT WAS REPORTED THAT BD PHASEAL¿ SECONDARY SET C61 LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN WARD, WHERE THEY ARE GIVING CYTOSTATICS TO PATIENT, THEY FOUND OUT A LEAKAGE FROM C61. LEAKAGE CAME FROM TUBE, WHERE IT CONNECTS TO SPIKE. TWO PATIENTS AND A NURSE EXPOSED TO CYTOTOCSIC STEAM.

  Patient problems: Chemical Exposure

  MAUDE report 8597196 ↗
• MalfunctionMay 3, 2019Fluid/Blood Leak

  IT WAS REPORTED THAT BD PHASEAL¿ SECONDARY SET C61 LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOR 17/4/2019 CASE, PRIMING WAS DONE AND DURING THE USUAL CHECK, NO LEAKAGE OCCURRED. IT WAS LATER AFTER THE DRUG (UROMITEXAN, NON-CYTOTOXIC) WAS ADDED INTO THE BOTTLE, THAT THE LEAKAGE MANIFESTED. WE MANAGED TO SALVAGE THE PREPARATION BY PLUGGING THE PORT WITH C90 AND USING ANOTHER PORT (OTHERWISE THE WHOLE PREPARATION WOULD BE UNUSABLE). THE AFFECTED C61 WAS PULLED OUT AND STUCK INTO ANOTHER PARTIAL ¿CLEAN¿ DRIP BOTTLE (CONTAINING STERILE WATER). THE PHARMACIST IS USING THE PRODUCT AND THERE¿S NOT PHYSICAL HARM TO THE USER OR PATIENTS DUE TO THE LEAKAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8577991 ↗
• MalfunctionApr 30, 2019Leak/Splash

  IT WAS REPORTED THAT DURING USE OF THE BD PHASEAL¿ SECONDARY SET C61 THERE WAS TUBE LEAKAGE AT THE CONNECTORS. THE INFUSION BAGS CONTAINING THE CYTOSTATIC SOLUTIONS HAD TO BE INTERRUPTED DURING TREATMENT AND BE DISCARDED. THUS, THE MG / ML CONCENTRATION OF THE THERAPY IS NO LONGER EXACTLY GUARANTEED AND NEW CYTOSTATIC SOLUTIONS HAVE TO BE RAISED. THE INFUSION HAD TO BE PREPARED AGAIN. FOR CERTAIN PRODUCTS, UNFORTUNATELY, IN THE PHARMACY WAS NOT ENOUGH IN STOCK TO RE-MANUFACTURE THIS AGAIN, THE PATIENT HAD TO BE SENT HOME, AND INVITED AGAIN FOR THERAPY, F.EG. INCLUDING NEW BLOOD SAMPLES FOR THE LABORATORY. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: END OF (B)(6) 2019: THE PROBLEM PERSISTS, THERE ARE MORE AND MORE INCIDENTS. THE TUBING STILL DRIPS OUT AT THE SPIKE CLOSURE / BEGINNING OF TUBING! IN EVERYDAY BUSINESS ONE CAN NOT WORK ANYMORE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8567019 ↗
• MalfunctionApr 22, 2019Leak/Splash

  IT WAS REPORTED THAT BD PHASEAL¿ SECONDARY SET C61 LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS PARTICULAR UNIT IS AVAILABLE FOR YOUR COLLECTION IF REQUIRED. NO CYTOTOXIC DRUG HAD BEEN IN CONTACT/INSERTED YET, IT¿S JUST PLAIN NORMAL SALINE. PRIMING WAS DONE ACCORDING TO PROCEDURE. DURING THE USUAL CHECK BEFORE FURTHER DISINFECTION, WE WOULD GIVE THE BAG A SQUEEZE TO CONFIRM IF THERE¿S ANY LEAK. AT THIS POINT, LEAKAGE WAS DETECTED. UPDATED INFO: 1) THE PHARMACIST IS USING THE PRODUCT WHEN INCIDENT OCCURRED. 2) THERE¿S NO PHYSICAL HARM TO THE PERSONNEL FOR COMPLAINT ASSOCIATED TO LEAKAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8535868 ↗