BD PhaSeal 515306Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00382905153068), received between Dec 8, 2017 and Jan 30, 2026 — classified as 1 injury, 53 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (18 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 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Insufficient Flow or Under Infusion

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24225278 ↗
• MalfunctionJan 15, 2026Leak/Splash

  EVENT DETAILS: LEAKAGE FROM INFUSION BAG, SAMPLE IS AVAILABLE AND CYTOTOXIC. DURING USE FOLLOW UP RESPONSE RECEIVED ON -12/31/2025. PLEASE NOTE THAT THERE WAS NO PATIENT OR USER HARMED. FLUID THAT LEAKED CONTAINED DOXORUBICIN, DOCETAXEL. FOLLOW UP RESPONSE RECEIVED ON -1/8/2026. PLEASE CONFIRM: WAS THE INFUSION ADAPTER FULLY INSERTED WHEN THE LEAKAGE OCCURRED? ANSWER: YES, IT WAS FULLY INSERTED. WAS THERE ANY DAMAGE NOTED ON THE INFUSION BAG? ANSWER: NO WHAT BRAND IV BAG WAS USED? ANSWER: BAXTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24088910 ↗
• MalfunctionOct 30, 2025Leak/Splash; Leak/Splash

  EVENT DETAILS: THE NSS BAG WAS SEEN LEAKING FROM THE HEAD SECTION OF THE INFUSION ADAPTER C100 AFTER DISCUSSING WITH THE CUSTOMER, IT WAS CONFIRMED THAT THE SEPTUM HAD NOT BEEN PUNCTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426852 ↗
• MalfunctionSep 2, 2025Break; Break

  IT IS REPORTED BROKEN SPIKE. EVENT DESCRIPTION: PICTURE OF BROKEN SPIKE DURING CYTO PREPARATION WHEN DID THE INCIDENT OCCUR? BEFORE USE THE FRACTURE WAS FROM SHORTLY AFTER THE PREPARATION WITH THE SENDING OF THE IV TO THE SERVICE. WE 'CLAP' THE INFUSION IN HALF TO BE ABLE TO SEND, WHICH PRESUMABLY PUTS EXTRA PRESSURE ON THE DEVICE. SEE PHOTO. BOTH RUPTURES MAY HAVE HAPPENED BY CHANCE WITH A CARBOPLATIN INFUSION, GIVEN THAT THEY ARE ALSO THE LARGEST AND MOST INFUSIONS THAT WE SEND OUT THIS WAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22936591 ↗
• MalfunctionAug 14, 2025Leak/Splash; Leak/Splash

  IT IS REPORTED LEAKAGE. EVENT DESCRIPTION: THE MEDICATION WAS SEEN LEAKING FROM THE HEAD SECTION OF THE INFUSION ADAPTER C100. IN DESCRIPTION IT WAS MENTIONED AS "THE MEDICATION WAS SEEN LEAKING FROM THE HEAD SECTION OF THE INFUSION ADAPTER C100". KINDLY CONFIRM IF THERE IS ANY PATIENT INJURY HAPPENED. THE PATIENT DID NOT SUSTAIN ANY INJURY AS THE ISSUE OCCURRED BEFORE ADMINISTERING MEDICATION TO THE PATIENT. PLEASE FOLLOW UP TO VERIFY THE SPECIFIC LOCATION OF THE LEAK: THE CONNECTION INTERFACE. ARE THEY REFERRING TO THE SPIKE? NOT THE SPIKE. WAS THE LEAK THROUGH THE MEMBRANE? UNKNOWN. WAS IS WHERE THE TUBING CONNECTS? NOT CONNECTED TO THE TUBING; THE LEAKAGE OCCURRED BEFORE CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22809020 ↗
• MalfunctionApr 27, 2025Disconnection; Disconnection

  THE FOLLOWING WAS REPORTED VIA EMAIL: PRODUCT DETAILS ¿ PRODUCT NAME: PHASEAL INFUSION ADAPTER (C100) ¿ MATERIAL/CATALOGUE NUMBER: 515306 ¿ LOT NUMBER(S): 2411207 ¿ DATE OF INCIDENT: (B)(6) 2025 ¿ DESCRIPTION OF EVENT (PLEASE PROVIDE SPECIFIC DETAILS OF THE ISSUE YOU EXPERIENCED): DURING PACKING, THE SEPTUM ON THE C100 POPPED OUT, CAUSING A SPILL INSIDE THE CLEAR PLASTIC BAG. WE DO NOT USE OR TAMPER WITH THE SIDE PORT. THE HOLE LEFT BY THE POPPED SEPTUM RESULTED IN EXCESSIVE LEAKAGE. ¿ SAMPLE AVAILABILITY: NO. ¿ IF THE EVENT INVOLVED ANY OF THE FOLLOWING, PLEASE INCLUDE PROVIDE ADDITIONAL DETAIL: - DEATH/SERIOUS INJURY - NO. - ERRONEOUS RESULTS - NO. - EXPOSURE TO BLOOD/BODILY FLUIDS - NO. - SAFETY ISSUE - HAD THE PRODUCT NOT BEEN BAGGED IN A CLEAR PLASTIC BAG, IT COULD HAVE RESULTED IN A SIGNIFICANT LEAK, POTENTIALLY AFFECTING A STAFF MEMBER OR PATIENT. - MEDICAL INTERVENTIONS REQUIRED - NO. ¿ PICTURES/VIDEOS (IF POSSIBLE) CLEARLY SHOWING THE INCIDENT/DEFECT - ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21915964 ↗
• MalfunctionMar 4, 2025Air/Gas in Device; Air/Gas in Device

  DESCRIPTION/EVENT DETAILS: HCP HAS ALERTED ME THAT WHEN THEY ARE INFUSION CHEMO THROUGH THE PHASEAL SYSTEM SOMEHOW AIR IS GETTING INTO THE LINE BELOW THE DRIP CHAMBER BUT THERE IS STILL FLUID IN THE IV BAG. CAUSING NURSES TO CIRCLE PRIME THE LINE AND RISK OF LOSING COSTLY MEDICATION. HE DOES NOT KNOW WHAT IS CAUSING IT BUT IT HAS INCREASED IN OCCURRENCE SINCE STARTING PHASEAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21514995 ↗
• MalfunctionFeb 4, 2025Infusion or Flow Problem; Infusion or Flow Problem

  DESCRIPTION EVENT DETAILS: UNINTENTIONAL / ACCIDENTAL CYTOTOXIC EXPOSURE. FROM THE REPORT: THIS OCCURRED AT THE HOSPITAL ON (B)(6) 2025, CUSTOMER DID NOT STATE AT WHICH STAGE. NO ACTUAL SAMPLE OR PHOTOGRAPHS WERE PROVIDED FOR INVESTIGATION DURING INITIAL REPORT. BAXTER COMPOUNDING SERVICES PRODUCT: CYCLOPHOSPHAMIDE PRODUCT, BATCH DETAILS REQUESTED. CUSTOMER FORWARDED COMPLETED PV ANZ MEDICATION ERROR FORM ON (B)(6) 2025, WHICH CONFIRMED THIS EVENT INVOLVES AN UNINTENTIONAL / ACCIDENTAL CYTOTOXIC EXPOSURE EVENT. CUSTOMER REPORTED THAT "THE DRUG WAS NOT FLOWING THROUGH THE LINE/PUMP, SO WHEN THE CLAMP WAS REMOVED TO CREATE FLOW, THE DRUG SPURTED OUT THE AIR RELEASE VALVE". CUSTOMER REPORTED THAT THE CYTOTOXIC SPILL WAS CLEANED UP TO PREVENT EXPOSURE OF DRUG TO THE PATIENT AND OTHERS IN THE UNIT. ADDITIONAL COMMENTS INCLUDED "RN IN DAY ONCOLOGY WHILE TRYING TO TROUBLE SHOOT AN IV LINE THAT WOULD NOT PULL DRUG FROM THE IV BAG OF CYCLOPHOPHAMIDE WHILE USING THE BAXTER PUMP. IV LINE PREVIOUSLY USED TO ADMINISTER DOXORUBICIN WITH NIL ISSUES AS PER PROTOCOL. RN TRIED TO OPEN THE AIR VENT ON THE DRIP CHAMBER OF THE IV LINE. THE AIR VENT PLUG COMPLETELY DETACHED FROM THE LINE (BROKE) WHICH C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21303432 ↗
• MalfunctionFeb 3, 2025Infusion or Flow Problem; Infusion or Flow Problem

  DESCRIPTION EVENT DETAILS: I WANT TO RELAY FEEDBACK FROM ONE OF OUR CUSTOMERS USING BD PHASEAL INFUSION ADAPTER C100. THEY HAD FEW INCIDENTS WHERE SIGNIFICANT VOLUMES OF AIR HAVE COME INTO THE LINE DESPITE HAVING DRUG REMAINING IN THE BAG (WITH BD PHASEAL INFUSION ADAPTER C100 ATTACHMENT) AND THIS CAUSE SIGNIFICANT DISRUPTION DURING INFUSION. THEY WOULD LIKE TO KNOW IF YOU HAVE RECEIVED SIMILAR ISSUE WITH THIS PRODUCT ATTACHMENT AND IF YOU HAVE ANY RECOMMENDATIONS THAT WOULD BE MUCH APPRECIATED. ADDITIONAL INFORMATION WAS THE REPORTED EVENT ASSOCIATED WITH A SINGLE PATIENT OR MULTIPLE PATIENTS? IF IT INVOLVED MULTIPLE PATIENTS, KINDLY SPECIFY THE DATE OF OCCURRENCE. MULTIPLE PATIENTS DATE OF OCCURRENCE (B)(6) 2025. IN PREVIOUS RESPONSE RECEIVED AS KINDLY PROVIDE LOT NO. NOT AVAILABLE. PRODUCT WAS USED BY 3RD PARTY. COULD YOU KINDLY VERIFY IF THEY ARE QUALIFIED HEALTHCARE PROFESSIONALS? YES THEY ARE QUALIFIED HOSPITAL STAFF. BASED ON ABOVE RESPONSE RECEIVED A FOLLOW DONE ON BELOW QUESTIONS: REQUESTING THE RESPONSE FOR ADDITIONAL DETAILS MENTIONED BELOW. COULD YOU PLEASE CONFIRM THE NUMBER OF PATIENTS WHO HAVE BEEN IMPACTED? COULD YOU PLEASE CONFIRM IF ALL THE PATIENTS ARE AFFECTED B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293162 ↗
• MalfunctionJan 23, 2025Infusion or Flow Problem; Infusion or Flow Problem

  DESCRIPTION/EVENT DETAILS: I WANT TO RELAY FEEDBACK FROM ONE OF OUR CUSTOMERS USING BD PHASEAL INFUSION ADAPTER C100. THEY HAD FEW INCIDENTS WHERE SIGNIFICANT VOLUMES OF AIR HAVE COME INTO THE LINE DESPITE HAVING DRUG REMAINING IN THE BAG (WITH BD PHASEAL INFUSION ADAPTER C100 ATTACHMENT) AND THIS CAUSE SIGNIFICANT DISRUPTION DURING INFUSION. ADDITIONAL INFORMATION: WHEN DID THE INCIDENT OCCURRED (BEFORE, DURING OR AFTER USE) DURING USE DATE OF OCCURRENCE (B)(6)2025 QUANTITY INVOLVED (B)(4) KINDLY PROVIDE LOT NO. NOT AVAILABLE. PRODUCT WAS USED BY 3RD PARTY. IS THE IV LINE IS VENTED OR NON-VENTED? NON VENTED. COULD YOU PROVIDE INFORMATION FOR THE MEDICATION/CONTAINER THAT IS BEING USED AS WELL? RITUXIMAB BAGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21218719 ↗
• MalfunctionJul 19, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19782003 ↗
• MalfunctionJul 19, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19781955 ↗
• MalfunctionJul 17, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MET WITH (B)(6) TO FURTHER UNDERSTAND THE PIR'S BELOW: (B)(6). (B)(6) ARE EXPERIENCING A "FOREIGN MATTER" IN THE IV BAGS, IT LOOKS SMALL AND WHITE WITH A POTENTIAL PLASTIC NATURE. SHE IS UNSURE WHERE THIS IS COMING FROM, POSSIBLY PHASEAL? (B)(6) BOUGHT ALONG SOME OF THE BAGS WITH THE "FOREIGN MATTER". WE LOOKED FOR A GOOD 20 MINUTES TRYING TO FIND THIS MATTER, I WAS ABLE TO IDENTIFY ONE WHICH I TOOK PHOTOS OF. THE REST I COULD NOT IDENTIFY, BUT IT IS SO SMALL THAT IT'S HARD TO SEE. IT'S MAINLY WITH TRASTUZUMAB (GREY VIAL BUNG) AND RITUXIMAB (GREY VIAL BUNG) BUT CAN OCCUR WITH OTHER DRUGS. ITS HAPPENING IN BAXTER PVC AND NON PIVC BAG. NO DRAWING UP NEEDLE USED. THEY HAVE A STRICT INSPECTION POLICY FOR LOOKING FOR FOREIGN MATTER, IN ALL CASES IT HAS NOT OCCURED UNTIL THEY ATTACH INJECTOR (515003) TO THE BAG ADAPTER (515306). SO THEY CHECK THE SYRINGE BEFORE INJECTING INTO BAG AND AREN'T SEEING THE MATTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19760036 ↗
• MalfunctionDec 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  CHEMOTHERAPY MEDICATION SOLUTION LEAKAGE FROM THE INTERFACE OF SPIKE OF INFUSION ADAPTER C100 AND RUBBER PORT OF IV BAG (PSI- SAUDI ARABIA , IV SOLUTION MANUFACTURER). THEY HAD FEW CASES OF LEAKAGE PREVIOUSLY ALSO. NOW THERE ARE NEW CASES REPORTED RECENTLY. BD PHASEAL INFUSION ADAPTER C100. 04DEC2023: PER REP: THE MAIN COMPLAINT OF CUSTOMER IS LEAKS AT THE JUNCTION/INTERFACE OF INFUSION ADAPTER C100 WITH RUBBER PORT PSI IV SOLUTION BAGS, BUT LATER DURING SAMPLE COLLECTION THE CUSTOMER HAS CONFIRMED THAT BAXTER EMPTY TPN/ SALINE MULTI-PURPOSE IV BAGS IS ALSO SOMETIMES LEAKING AT ITS ACCESS RUBBER PORT JUNCTION WITH INFUSION ADAPTER C100, WHEN THEY PREPARE CHEMOTHERAPY IN BAXTER¿S EMPTY TPN/SALINE MULTI-PURPOSE IV BAGS AND USE WITH INFUSION ADAPTER C100. THE INCIDENCES INCREASING IN HOSPITAL, SO WE HAVE ARRANGED TRAINING SESSIONS WITH ALL END-USERS (PHARMACY & NURSING STAFF) OF BD PHASEAL INFUSION ADAPTER C100, FOCUSING FOR BEST PRACTICES ATTACHING C100 WITH IV BAGS. PER REP COMMUNICATION 05DEC2023: CHEMOTHERAPY MEDICATION SOLUTION LEAKAGE FROM THE INTERFACE OF SPIKE OF INFUSION ADAPTER C100 AND RUBBER PORT OF IV BAG (PSI- SAUDI ARABIA , IV SOLUTION MANUFACTURER). AND BAXTER EMPTY TP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18329094 ↗
• MalfunctionDec 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION PROVIDED: HAS THERE BEEN ANY PATIENT IMPACT (MEDICAL INTERVENTION, CHANGE OF TREATMENT REQUIRED)? NO, BUT DUE TO LEAKAGE OF CHEMOTHERAPY INFUSION, THEY STOPPED THAT LEAKAGE INFUSION AND PREPARE ANOTHER INFUSION BAG OF CHEMOTHERAPY TO COMPLETE THE TREATMENT PROCESS. HAS THERE BEEN ANY HEALTHCARE WORKER¿S EXPOSURE TO BLOOD OR BODILY FLUIDS? HCW EXPOSED TO HAZARDOUS DRUG DUE TO LEAKAGE, NO BLOOD, OR BODILY FLUIDS EXPOSURE. HAVE ANY OTHER ACTIONS BEEN TAKEN? WE HAVE ARRANGED PRODUCT TRAINING SESSIONS WITH END-USERS PHARMACY TECHNICIANS AND ONCOLOGY NURSING STAFF HIGHLIGHTING BEST PRACTICES USING PHASEAL SYSTEMS - ATTACHING C100 INFUSION ADAPTER PROPERLY.

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

  MAUDE report 18329082 ↗
• MalfunctionSep 26, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ INFUSION ADAPTER C100 LEAKED CHEMOTHERAPY MEDICATION FROM THE INTERFACE PORT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKING OF CHEMOTHERAPY DRUG FROM INTERFACE PORT OF RUBBER PORT OF IV BAG AND BD INFUSION ADAPTOR." THERE WAS NO IMPACT ON PATIENT/HCP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821594 ↗
• MalfunctionSep 20, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ INFUSION ADAPTER C100 EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPON RECEIVING ADRIAMYCIN IVPB IN CHEMO BAG, AS I WAS SCANNING THE BARCODE I NOTICED A SMALL DROPLET ON THE OUTSIDE TUBING NEAREST THE INSERTION SITE ON THE BAG. VERBATIM: BD PHASEAL INFUSION ADAPTER C100 REF 515306, LOT 2201217 MANUFACTURE DATE 2022-01-01 EXP 2025-12-31.UPON RECEIVING ADRIAMYCIN IVPB IN CHEMO BAG, AS I WAS SCANNING THE BARCODE I NOTICED A SMALL DROPLET ON THE OUTSIDE TUBING NEAREST THE INSERTION SITE ON THE BAG, I INSPECTED THE REST OF THE TUBING AND BAG OF ADRIAMYCIN AND FOUND NO MORE DROPS. THE LINE HAD BEEN PRIMED WITH SALINE PER FACILITY PROTOCOL. IT IS SUSPECTED THAT THERE WAS A MEMBRANE DISFUNCTION AT THE PHASEAL CONNECTOR PORT. PLEASE LET ME KNOW IF YOU HAVE ANY QUESTIONS. RESPONSE RECEIVED ON 18-SEP-2023: 1. ARE YOU ABLE TO CONFIRM IF THERE WAS ANY PATIENT INVOLVEMENT? IF YES, WHAT WAS THE PATIENT OUTCOME? - 1. NO PT INVOLVEMENT. 2. WAS THERE ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED? - 2. NO ADVERSE EVENT OR SERIOUS INJURY. 3. PLEASE CONFIRM THE DATE OF INCIDENT. - 3. 8/23/23. 4. ARE YOU ABLE TO PROVIDE THE QUA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17786032 ↗
• MalfunctionSep 11, 2023Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT THE BD PHASEAL¿ INFUSION ADAPTER C100 HAD FLOW ISSUES WITH AIR ENTERING THE INFUSION SET THROUGH THE VENT LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN THEY ARE USING THE ADAPTER WITH A CODAN INFUSSIONSET IT´S COMING AIR IN TO THE INFUSSIONSET. 1.09.2023 UPDATE : IT WAS A VENT LINE... IT WAS A PLASTIC CONTAINER. I HAVE INFORMED THE CUSTOMER THAT IT SHOULD BE CLOSED THEN THEY ARE USING A VENTED LINE."

  Patient problems: Insufficient Information

  MAUDE report 17725958 ↗
• MalfunctionJun 19, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD PHASEAL¿ INFUSION ADAPTER C100 EXPERIENCED FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THE REGISTERED NURSE "CHANGED THE PUMP RUNNING THE MYOZYME 3 TIMES INCLUDING THE LINES AND HAD THE PATIENT RE-CANNULATED MULTIPLE TIMES, IN CASE IT WAS A VEIN COLLAPSE SITUATION. EACH CHANGE STILL RESULTED IN A LINE OCCLUSION ERROR. THE ONLY WAY THEY COULD GET THE INFUSION TO RUN, WAS WITH THE REMOVAL OF THE INLINE FILTER, WHICH IS MANDATED BY THE DATA SHEET AND CONSUMER INFORMATION. A VISUAL INSPECTION OF THE BAG HASN¿T REVEALED ANY ¿PARTICLES¿, BUT THE ALARMING OF THE PUMP SUGGESTS THAT THERE IS SOMETHING CAUSING A BLOCKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159411 ↗
• MalfunctionApr 13, 2023Contamination; Contamination

  IT WAS REPORTED THAT THE BD PHASEAL¿ INFUSION ADAPTER C100 CORED THE RUBBER STOPPER IN THE MEDICATION VIAL DURING USE. THIS OCCURRED WITH 3 INFUSION ADAPTERS. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE HOSPITAL SITE HAS REPORTED AN ISSUE WITH THE PHASEAL PRODUCT USING THE PHARMASCIENCE BRAND OF BORTEZOMIB 3.5 MG POWDER. THE ONCOLOGY TEAM ADDED A PHASEAL ADAPTOR AND TRIED TO ADD LIQUID, WHICH WOULD NOT PUSH IN. NEXT, THEY TRIED A SECOND VIAL AND ADDED PHASEAL, BUT NO LIQUID WOULD PUSH IN, AND THE RUBBER RIPPED OUT OF THE THIRD VIAL. HEALTHPRO NOTE: THE HOSPITAL SITE HAS INDICATED THAT THE PHASEAL ADAPTOR WORKS FINE ON ALL OTHER BRANDS OF BORTEZOMIB. THIS PRODUCT CONCERN IS ONLY REPORTED FOR THE PMS BRAND OF BORTEZOMIB 3.5 MG POWDER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16740500 ↗
• MalfunctionApr 13, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE BD PHASEAL¿ INFUSION ADAPTER C100 HAD FLOW ISSUES WITH THE BORTEZOMIB DURING THE INFUSION. THIS OCCURRED WITH 3 INFUSION ADAPTERS. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE HOSPITAL SITE HAS REPORTED AN ISSUE WITH THE PHASEAL PRODUCT USING THE PHARMASCIENCE BRAND OF BORTEZOMIB 3.5 MG POWDER. THE ONCOLOGY TEAM ADDED A PHASEAL ADAPTOR AND TRIED TO ADD LIQUID, WHICH WOULD NOT PUSH IN. NEXT, THEY TRIED A SECOND VIAL AND ADDED PHASEAL, BUT NO LIQUID WOULD PUSH IN, AND THE RUBBER RIPPED OUT OF THE THIRD VIAL... HEALTHPRO NOTE: THE HOSPITAL SITE HAS INDICATED THAT THE PHASEAL ADAPTOR WORKS FINE ON ALL OTHER BRANDS OF BORTEZOMIB. THIS PRODUCT CONCERN IS ONLY REPORTED FOR THE PMS BRAND OF BORTEZOMIB 3.5 MG POWDER.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16740499 ↗
• MalfunctionApr 13, 2023Contamination; Contamination

  IT WAS REPORTED WHILE USING BD PHASEAL¿ IV BAG/LINE ACCESS DEVICES FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PROBLEM DESCRIPTION: OPENED A SEALED PACKAGE AND NOTICED BROWN SPOTS ON THE PLASTIC - APPEARS DIRTY, AND NOT STERILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16740496 ↗
• MalfunctionApr 11, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ INFUSION ADAPTER C100 LEAKED WHEN USED WITH THE LIPOSOMAL DOXORUBICIN BAG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACIST. REPORTED 1 LIPOSOMAL DOXORUBICIN BAG HAD A LEAK IN THE ONCOLOGY DAY UNIT WHEN THEY OPENED THE BAG. THE LEAK IS ORIGINATING FROM THE ANCILLARY ITEM PROVIDED WITH THE PRODUCT; PHASEAL ADAPTOR. FURTHER INFORMATION REQUESTED FROM CUSTOMER. INCLUDING WHETHER ANY LEAK WAS OBSERVED PRIOR TO REMOVING PRODUCT FROM OVERPOUCH, AT WHICH STAGE EXACTLY THE LEAK WAS IDENTIFIED, WHETHER THERE WAS ANY SKIN CONTACT WITH ANY SPILLED CYTOTOXIC SOLUTION AND IF SKIN CONTACT OCCURRED, WHAT ACTIONS WERE TAKEN IMMEDIATELY AFTER ANY SPILL SKIN CONTACT, WHETHER THERE WAS ANY REPORT OF STAFF / PATIENT INJURY, OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT, AND WHETHER THERE WAS ANY DAMAGE OBSERVED TO THE PHASEAL ADAPTOR, THE PRODUCT PACKAGING, OR THE CARTON THE PRODUCT WAS RECEIVED IN. THIS WAS IDENTIFIED AT THE HOSPITAL ON (B)(6) 2023."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16714625 ↗
• MalfunctionMar 13, 2023Contamination; Contamination

  IT WAS REPORTED THAT THE BD PHASEAL¿ INFUSION ADAPTER C100 EXPERIENCED FOREIGN MATTER IN FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ENDUSER USE BD PHASEAL FOR ONCOLOGY DRUG COMPOUNDING. PARTICLES HAVE BEEN FOUND IN DRUG VIAL X1 AND SALINE BAG X1. PARTICLES ARE SUSPECTED TO BE CAUSED BY CORING WHEN USER INSERT BD PROTECTOR ONTO THE VIAL OR WHEN INSERTING INFUSION ADAPTOR INTO THE SALINE BOTTLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16530940 ↗
• MalfunctionNov 9, 2022Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT 7 BD PHASEAL¿ IV BAG/LINE ACCESS DEVICES EXPERIENCED FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AIR IN THE SYSTEM. WE HAVE HAD A BIG PROBLEM WITH THE NEW INFUSION SETS FROM IN COMBINATION WITH PHASEAL'S ADAPTER FOR ANTIBIOTIC MIXING THE LAST FEW DAYS. WHEN USING THESE TWO TOGETHER, THE ENTIRE DRIP CHAMBER FILLS WITH AIR AND SPREADS OUT INTO THE DRIP LINE. WE HAVE HAD NO PROBLEMS WITH AIR INTAKE WHEN THE UNIT IS USED ALONE FOR INFUSIONS. IT IS AN AUTOMATIC SELF-REGULATING VALVE ON THE UNITS THAT SHOULD ONLY BE OPEN FOR INFUSIONS FROM A GLASS BOTTLE. WE HAVE OF COURSE TRIED BOTH WITH THE VALVE OPEN AND CLOSED BUT WITH THE SAME RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15761336 ↗