BD PhaSeal 515003Recalls & reported problems

Summary

The FDA's MAUDE database contains 183 adverse event reports that list this exact device (DI 00382905150036), received between Oct 23, 2017 and Dec 2, 2025 — classified as 6 injuries, 177 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (72 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 183 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694124 ↗
• MalfunctionJun 23, 2025Leak/Splash; Leak/Splash

  IT IS REPORTED LEAKAGE. EVENT DETAILS: DURING RECONSTITUTION OF METHOTREXATE USED FOR ECTOPIC PREGNANCY WITH THE BD PHASEAL¿ SYSTEM KIT PART NUMBERS 515003 (INJECTOR®), 515100 (PROTECTOR®), AND BATCHES 2408005 (INJECTOR®) AND 2406113 (PROTECTOR®); A LEAKAGE OF THE PRODUCT IS OBSERVED. IN FACT, THE NURSE CONNECTS THE SYRINGE TO THE KIT AND INJECTS AIR INTO THE BOTTLE IN ACCORDANCE WITH THE MANUFACTURER'S RECOMMENDATIONS. AS SHE DREW IN THE CONTENTS WITH THE SYRINGE, A LEAKAGE OF PRODUCT WAS OBSERVED BETWEEN THE INJECTOR® AND THE PROTECTOR®, AND THE PRODUCT DRIPPED ONTO THE NURSE'S OPEN FIELD AND GLOVES. THE ENTIRE BOTTLE LEAKED. THE NURSE USED ANOTHER KIT WITH THE SAME REFERENCES AND UNKNOWN BATCHES, TO SUCCESSFULLY ADMINISTER THE PRESCRIBED DOSAGE OF METHOTREXATE. NUMBER OF PATIENTS OR PERSONS CONCERNED: 1. NUMBER OF DEVICES INVOLVED: 1. CLINICAL CONSEQUENCES AND CURRENT STATUS OF PATIENT OR PERSON INVOLVED: EXPOSURE OF NURSING STAFF TO A HAZARDOUS SUBSTANCE AS A RESULT OF METHOTREXATE SPILLAGE (BUT NO DIRECT CONTACT WITH ORAL OR OCULAR SKIN OR MUCOUS MEMBRANES). NO CLINICAL CONSEQUENCES FOR THE PATIENT. TIME LOST: 10 MINUTES WHILE ANOTHER KIT IS USED.

  Patient problems: Chemical Exposure

  MAUDE report 22307660 ↗
• MalfunctionJun 16, 2025Infusion or Flow Problem; Infusion or Flow Problem

  VERBATIM: POST INVESTIGATION FINDINGS SHOWED DAMAGE TO THE SAFETY SLEEVE OF THE JAWS. NEEDLE OF SAMPLE WAS NOT EXPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22216054 ↗
• MalfunctionJun 2, 2025Material Integrity Problem; Material Integrity Problem

  EVENT DETAILS: THE BLUE PORTION OF THE INJECTOR RETRACTED AS EXPECTED BUT DID NOT FULLY PROTRACT, EXPOSING THE NEEDLE AND RESULTING IN A NEAR MISS NEEDLE STICK INJURY. PHASEAL INJECTOR LUER LOCK. LOT: 2501001. EXPIRY: 30/06/2027. 1. KINDLY PROVIDE THE PRODUCT NUMBER: 515003. 2. KINDLY PROVIDE THE EVENT OCCURRENCE DATE: (B)(6) 2025. 3. KINDLY PROVIDE NUMBER OF OCCURRENCES: 1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22122490 ↗
• MalfunctionApr 24, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  DESCRIPTION: BEFORE USE. IN THE MEDICAL ONCOLOGY - WHEN THE SYRINGE ADAPTER WAS CONNECTED TO THE VIAL ADAPTER TO DILUTE THE POWDER VIAL, A VERY SMALL AMOUNT OF LIQUID FLOW WAS OBSERVED. FOR CONTROL PURPOSES, THE SYRINGE ADAPTER WAS SEPARATED FROM THE VIAL ADAPTER. AT THIS TIME, THE NEEDLE INSIDE THE SYRINGE ADAPTER REMAINED COMPLETELY OUTSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900970 ↗
• MalfunctionMar 25, 2025Leak/Splash; Connection Problem; Leak/Splash; Connection Problem

  NO ADDITIONAL INFORMATION.

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

  MAUDE report 21687106 ↗
• MalfunctionMar 25, 2025Leak/Splash; Connection Problem; Leak/Splash; Connection Problem

  NO ADDITIONAL INFORMATION.

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

  MAUDE report 21687102 ↗
• MalfunctionJan 9, 2025Leak/Splash; Leak/Splash

  DESCRIPTION OF INCIDENT: WHEN METHOTREXATE USED FOR ECTOPIC PREGNANCY WAS RECONSTITUTED WITH THE BD PHASEAL¿ SYSTEM INJECTOR, REFERENCE: 515003 AND LOT UNKNOWN, METHOTREXATE WAS FOUND TO FLOW OUT OF THE INJECTOR. INDEED, WHEN THE NURSE TRIED TO REMOVE THE INJECTOR FROM THE METHOTREXATE VIAL, LIQUID FLOWED AROUND THE NEEDLE CASING. FINALLY, THE NURSE USED A SECOND INJECTOR OF IDENTICAL REFERENCE AND UNKNOWN BATCH TO REPEAT THE PROCEDURE, LEADING TO THE SAME INCIDENT. THE SAME INCIDENT. OPENING A THIRD INJECTOR OF IDENTICAL REFERENCE AND UNKNOWN BATCH, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CLINICAL CONSEQUENCES: EXPOSURE OF NURSING STAFF TO A HAZARDOUS SUBSTANCE METHOTREXATE SPILLAGE. TO DATE NO CLINICAL CONSEQUENCES HAVE BEEN OBSERVED FOR PATIENTS OR STAFF. ACTIONS TAKEN AT THE PLANT: OPENING OF 3 INJECTORS AND 4 VIALS OF METHOTREXATE. THE DEVICE IS NOT AVAILABLE FOR EXPERT APPRAISAL. COULD YOU CONFIRM IF THE LEAK OCCURRED INSIDE THE INJECTOR PLUNGER OR BETWEEN THE INJECTOR AND THE SYRINGE? ANSWER: BETWEEN THE INJECTOR AND THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112230 ↗
• MalfunctionJan 8, 2025Disconnection; Disconnection

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103037 ↗
• MalfunctionJan 5, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  MATERIAL#: 515003. BATCH NUMBER#: UNKNOWN. VERBATIM#: HOPE YOU HAD A WONDERFUL CHRISTMAS, OVER LAST 2 WEEKS WE HAVE 3 REPORTED CASES OF LEAK AT THE CONNECTION POINT BETWEEN ICU MEDICAL TUBING AND PHASEAL INJECTOR LUER LOCK. HENCE WANTED TO CHECK WITH YOU IF THIS IS SOMETHING YOU MAY HAVE HEARD FROM ANY OTHER SITE AS WELL. HAS HAPPENED OVER THE PAST FEW WEEKS--AS I WAS MADE AWARE TODAY. APPARENTLY THE THIRD TIME WAS TODAY AND PROMPTED THE EMAIL TO ME. USE OF PHASEAL WITH CADD-ICU PUMP... FIXED MALE LUER CONNECTION ¿ WHILE BEING USED ON A PATIENT? YES ¿ WHAT HAPPENED¿ THE CONNECTION GOT UNSCREWED AND EXTENSION SET WAS DISCONNECTED ¿ WHAT TYPE OF PROCEDURE? CHEMO INFUSION ¿ PRODUCT: DO YOU HAVE THE AFFECTED TWO ITEMS THAT LEAKED? WERE THEY DISCARDED? ITEMS WERE DISCARDED ¿ LOT # CAN YOU PLEASE PROVIDE? AND WOULD YOU HAPPEN TO HAVE THE PACKAGING AS WELL? OR IS THE ATTACHED PICTURE THE REPRESENTATIVE LOT # FROM THE PARS? ATTACHED PICTURES ARE ONLY THING WE HAVE ¿ CAN YOU PLEASE PROVIDE THE EXPIRATION DATE-PLEASE? NOT AVAILABLE ¿ WAS THERE ANY PATIENT HARM? .NO IMMEDIATE HARM NOTICED, PATIENT EXPOSED TO THE 5FU HE WAS RECEIVING. AFTER HE MANUALLY CONNECTED THE POINTS AGAIN HE WENT TO ED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21076471 ↗
• MalfunctionNov 22, 2024Leak/Splash; Leak/Splash

  MATERIAL #: 515003; BATCH#: UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT PHASEAL ATTACHED TO AVANOS ELASTOMERIC PUMP WHICH CONTAINED FLUOROURACIL, UPON PUMP DECONTAMINATION IT WAS NOTED TO CONTAIN RESIDUE OF THE DRUG ON PHASEAL BLUE INTERIOR INDICATING THAT THE MED LEAKED OUT OF INNER NEEDLE CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20757064 ↗
• MalfunctionSep 10, 2024Break; Break

  THE FOLLOWING WAS REPORTED VIA EMAIL:PLEASE FIND ATTACHED A SECOND QUALITY DEFECT REPORT CONCERNING: BD PHASEAL INJECTOR LUER LOCK REF : 515003 LOT: 2404004 THE ENTIRE BATCH PRESUMED TO BE DEFECTIVE AS WELL AS THE INJECTOR CONCERNED BY THIS NEW INCIDENT ARE KEPT AT THE PUI, SINCE THIS IS THE SECOND INCIDENT REPORTED ON THIS BATCH, WOULD A REFUND OR EXCHANGE BE POSSIBLE? THE QUANTITY CONCERNED IS 8 INJECTORS. CIRCUMSTANCES / DESCRIPTION: AS SHE WITHDRAWS FROM THE PHASEAL SYSTEM PROTECTOR, THE STITCHER SEES THE INJECTOR CANULA STUCK IN THE SEPTUM. AFTER DISENGAGEMENT WITH DIFFICULTY, THE CANULA REMAINS OUTSIDE. CONSERVATION MEASURES AND ACTIONS TAKEN : THE INJECTOR WAS KEPT AT THE PUI MANUFACTURER AND INJECTOR DECLARATION AVAILABLE FOR ANALYSIS. WHOLE LOT KEPT (8 INJECTORS) REQUEST EXCHANGE OR REFUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20180669 ↗
• MalfunctionSep 9, 2024Break; Break

  DATE OF OCCURRENCE: (B)(6) 2024. NATURE OF DQ: AS THE STITCHER WITHDRAWS FROM THE PHASEAL SYSTEM PROTECTOR, THE INJECTOR CANULA BECOMES STUCK IN THE SEPTUM. CIRCUMSTANCES / DESCRIPTION: AS THE STITCHER WITHDRAWS FROM THE PHASEAL SYSTEM PROTECTOR, THE INJECTOR CANULA BECOMES STUCK IN THE SEPTUM. PRECAUTIONARY MEASURES AND ACTIONS TAKEN: THE INJECTOR WAS KEPT AT THE PUI DECLARATION MANUFACTURER AND INJECTOR AVAILABLE FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20173412 ↗
• MalfunctionAug 27, 2024Leak/Splash; Leak/Splash

  CLINICIANS REPORTED INSTANCES OF LEAKAGE FROM THE BASE OF THE PHASEAL INJECTOR DURING CERTAIN SUBCUT INJECTIONS. THEY STATED TRASTUZUMAB IS AN EXAMPLE OF A MEDICATION THAT WILL LEAK THROUGH THE INJECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20076697 ↗
• MalfunctionAug 23, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MATERIAL NUMBER PROVIDED BY CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20045173 ↗
• MalfunctionJul 19, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ANOTHER INCIDENT HAS OCCURRED. VISIBLE IN ATTACHED PHOTOS. OTHER PIRS: (B)(4). CAPITAL AND COAST 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? 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 19782076 ↗
• MalfunctionJul 19, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MET WITH NERISSA TO FURTHER UNDERSTAND THE PIR'S BELOW: (B)(4). CAPITAL AND COAST 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? NERISSA 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. TH REST I COULD NOT IDENTIFY, BUT IT IS SO SMALL THAT ITS 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 OCCURRED 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. PLEASE SEE ATTACHED PHOTOS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19782013 ↗
• MalfunctionJul 19, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ANOTHER INCIDENT HAS OCCURRED. OTHER PIRS: (B)(4). CAPITAL AND COAST 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? 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 19781933 ↗
• MalfunctionJul 11, 2024Defective Component; Defective Component

  MATERIAL # 515003 BATCH # UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THEY ARE HAVING DIFFICULTY IN GETTING THE PHASEAL INJECTOR TO ENGAGE INTO THE PHASEAL CONNECTOR ON THE PATIENT'S IV TUBING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ASSISTING RN IN ADMINISTERING 4 SYRINGES OF DOXORUBICIN TO PATIENT. ADMINISTERING RN WAS HAVING A DIFFICULT TIME GETTING THE PHASEAL INJECTOR TO ENGAGE INTO THE PHASEAL CONNECTOR ON THE PATIENT'S IV TUBING. AFTER A FEW ATTEMPTS, I TRIED TO DO IT AND ALSO COULD NOT GET THE PHASEAL TO ENGAGE NO MATTER HOW MANY WAYS I ATTEMPTED TO DO. WE TRIED ANOTHER SYRINGE TO SEE IF A DIFFERENT PHASEAL INJECTOR WOULD WORK BUT STILL HAD NO LUCK. WE ALSO TRIED ANOTHER PHASEAL CONNECTOR. EVENTUALLY AFTER SEVERAL TWISTS OF THE PHASEAL ATTEMPTING TO GET IT TO ENGAGE, THE NEEDLE BECAME EXPOSED AND THERE WAS VISIBLE CHEMOTHERAPY ON THE INSIDE OF THE PHASEAL INJECTOR. AT THIS POINT I MADE THE DECISION TO REMOVE THE BROKEN PHASEAL INJECTOR AND REPLACE IT WITH ONE FROM OUR SUREMED, AS WELL AS PLACED A NEW CONNECTOR. THIS WORKED WITHOUT ANY ISSUES. WE ATTEMPTED THE OTHER SYRINGES. 2 OF THE 4 WERE ABLE TO ENGAGE, BUT 2 REQUIRED THE PHASEAL INJECTOR TO BE REP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19725724 ↗
• MalfunctionMay 14, 2024Leak/Splash; Leak/Splash

  USER WAS USING INJECTOR LUER LOCK (N35) FOR RECONSTITUTION OF CHEMO DRUG AND REALIZED LEAKING FROM THE LUER LOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19310552 ↗
• MalfunctionApr 4, 2024Disconnection; Disconnection

  ONCOLOGY TEAM STAFF MEMBER EMAILED SPECIALIST TO REPORT THE PHASEAL ADAPTER ON 1 FLUOROURACIL SYRINGE FOR PATIENT RT WAS NOT SECURED PROPERLY. CUSTOMER THAT WHEN THE NURSE TWISTED THE ADAPTER INTO THE CANNULA, THE LUER LOCK WITHIN THE SYRINGE CAME LOOSE AND DETACHED FROM THE SYRINGE. CUSTOMER CONFIRMED THIS DID NOT RESULT IN CYTOTOXIC EXPOSURE TO THE NURSE. NO THIRD PARTY NOTIFICATION IS REQUIRED FOR THIS EVENT AS THE ANCILLARY ATTACHMENT IS ADDED DURING THE COMPOUNDING OF THIS PRODUCT, IF THERE WERE ANY QUALITY ISSUES WITH THE ANCILLARY ATTACHMENT, THIS WOULD HAVE BEEN IDENTIFIED DURING COMPOUNDING AND ATTACHMENT REJECTED; COMPOUNDING INVESTIGATION ONLY REQUIRED. QA SPECIALIST FORWARDED ADDITIONAL INFORMATION FROM CUSTOMER CONFIRMING NO LEAK OCCURRED DURING THIS EVENT. CUSTOMER REPORTED THERE WAS NO DAMAGE OBSERVED TO THE PRODUCT PACKAGING, OR THE CARTON THE PRODUCT WAS RECEIVED IN; PRIOR TO THE INCIDENT OCCURRING. CUSTOMER ALSO REPORTED THE PATIENT DID NOT MISS THEIR TREATMENT, THE PRODUCT WAS USED AS THE NURSE RE-ATTACHED THE ADAPTOR. CUSTOMER ALSO CONFIRMED THERE WAS NO REPORT OF PATIENT / STAFF INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT, HOWEVER STATED "POTENTIAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19047126 ↗
• MalfunctionMar 28, 2024Disconnection; Disconnection

  NO ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 18994156 ↗
• MalfunctionMar 28, 2024Disconnection; Disconnection

  MATERIAL#: 515003 LOT#: 2309005, 2308005 IT WAS REPORTED BY THE CUSTOMER REPORTED THAT THE N35 BECAME DISCONNECTED FROM THE HAZARDOUS CHEMOTHERAPY LINE, 2ND CASE OF THIS ISSUE. OUR PHARMACY TECHNICIAN AND NURSING BOTH CONFIRMED THAT THE N35 WAS SECURELY TIGHTENED BEFORE DISPENSING AND ADMINISTRATION. VERBATIM: THE N35 BECAME DISCONNECTED FROM THE HAZARDOUS CHEMOTHERAPY LINE, 2ND CASE OF THIS ISSUE. OUR PHARMACY TECHNICIAN AND NURSING BOTH CONFIRMED THAT THE N35 WAS SECURELY TIGHTENED BEFORE DISPENSING AND ADMINISTRATION.

  Patient problems: Insufficient Information

  MAUDE report 18991474 ↗
• MalfunctionMar 22, 2024Infusion or Flow Problem; Infusion or Flow Problem

  VERBATIM: FLUID CHEMO TRAPPED INSIDE THE INJECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18958403 ↗
• MalfunctionMar 20, 2024Leak/Splash; Leak/Splash

  MATERIAL#: 515003 LOT#: UNKNOWN IT WAS REPORTED BY THE CUSTOMER THAT THE EXPERIENCED ISSUES WITH BD PHASEAL INJECTORS LEAKING FROM THE LINE OR WHEN DISCONNECTED FROM THE TUBING. VERBATIM: THE CUSTOMER EXPERIENCED ISSUES WITH BD PHASEAL INJECTORS LEAKING FROM THE LINE OR WHEN DISCONNECTED FROM THE TUBING. ADDITIONAL INFORMATION: THERE WERE NO INTERVENTIONS REQUIRED DUE TO THE INCIDENT AND NO VISIBLE DAMAGE TO THE PRODUCT. UNFORTUNATELY WE DO NOT HAVE THE LOT #S AND THE PHYSICAL PRODUCTS WERE DISCARDED DUE TO ITS CONTACT WITH HAZARDOUS DRUGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18940855 ↗