BD PhaSeal Optima 515052Recalls & reported problems

Summary

The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 00382905150524), received between May 29, 2019 and Sep 9, 2026 — classified as 114 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (65 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, 2025Class IIOpen, 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 114 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50700896 ↗
• MalfunctionSep 9, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50700895 ↗
• MalfunctionSep 2, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50554668 ↗
• MalfunctionSep 1, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50554103 ↗
• MalfunctionAug 31, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50533104 ↗
• MalfunctionMar 30, 2026Disconnection

  IT WAS REPORTED THAT THE BD INJECTOR N35-O DISCONNECTED AT THE LUER LOCK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCONNECTION HAPPENED BETWEEN THE PHASEAL OPTIMA CONNECTOR AND THE FRESENIUS VOLUMAT LINE. INJECTOR AND CONNECTOR WERE STILL CONNECTED BUT THE DISCONNECTION HAPPENED BETWEEN THE PHASEAL OPTIMA AND THE FRESENIUS LINE. PER REP'S RESPONSE: THE VIDEO HAS BEEN WITHDRAWN AS IT WAS AN EVENT THAT WAS PREVIOUSLY REPORTED. THEY SENT IT WITH THE EMAIL NOTIFICATION BUT WAS NOT PART OF THIS EVENT. I HAVE SPOKEN TO THEM AND IT IS CLEAR THAT THE ONLY DISCONNECT HAPPENED BETWEEN THE FRESENIUS LINE AND THE INJECTOR PER REP: THE VIDEO IS NOT RELEVANT TO THIS EVENT. THEY DID NOT RETAIN THE DEVICE SO NOTHING TO RETURN. ADDITIONAL INFORMATION PROVIDED: THERE WAS A LEAKAGE THAT OCCURRED FROM THE END OF THE FRESENIUS LINE. NO PATIENT OR CLINICIAN INJURY. LINE WAS RECONNECTED AND TREATMENT COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24719619 ↗
• MalfunctionMar 19, 2026Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24644065 ↗
• MalfunctionMar 9, 2026Disconnection

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24551641 ↗
• MalfunctionFeb 24, 2026Contamination

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24437460 ↗
• MalfunctionFeb 9, 2026Disconnection; Leak/Splash

  IT WAS REPORTED THAT THE BD INJECTOR N35-O LUER LOCK DISCONNECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 515052 BATCH # 2402307 VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. AN RN ENTERED THE PATIENT'S ROOM TO FIND THE TACROLIMUS IV TUBING DISCONNECTED FROM BD PHASEAL N-35 INJECTOR. APPROXIMATELY 5ML OF MEDICATION WAS FOUND ON THE FLOOR. THE RN CONTAINED AND CLEANED THE SPILL. THE COVERING PROVIDER WAS NOTIFIED. PER NURSING NOTE: "PT'S TACRO TUBING BECAME DISCONNECTED AT THE SITE OF IV TUBING AND THE CHEMO SAFETY CHEMO CONNECTION. PHARMACY MIXED A NEW BAG. PURPLE LUMEN CAP CHANGED AND NEW BAG OF TACRO AND IT'S TUBING CHANGED AND STARTED IMMEDIATELY UPON ITS ARRIVAL " ADDITIONAL INFORMATION PROVIDED: 1. COULD YOU PLEASE PROVIDE THE MATERIAL & LOT NUMBER OF THE IV TUBING THAT WAS INVOLVED IN THIS EVENT ? UNKNOWN 2. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO HARM RESULTED, AS PHARMACY MIXED A NEW BAG OF TACRO, PURPLE LUMEN OF CENTRAL LINE WAS CHANGED, NEW PHASEAL CONNECTOR AND NEW TUBING WAS OBTAINED TO COMPLETE THE TREATMENT. 3. IN THE MEDSUN FORM MENTIONED THAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299821 ↗
• MalfunctionFeb 9, 2026Disconnection

  IT WAS REPORTED THAT THE INJECTOR N35-O LUER LOCK DISCONNECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 515052, BATCH # 2504306. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. DESCRIBE THE EVENT OR PROBLEM: CSTD (PHASEAL OPTIMA) INJECTOR POPPED OFF FROM THE PHASEAL OPTIMA CONNECTOR. THROUGHOUT THE SHIFT, THE RN ALSO NOTICED MULTIPLE TIMES THAT THE INJECTOR SCREW BECAME LOOSE, EVEN WITH FIRM SCREWING OF THE CONNECTOR ONTO THE IV LINES. THIS HAS HAPPENED DAILY FOR MONTHS. MANUFACTURER RESPONSE FOR OPTIMA PHASEAL, BD PHASEAL¿ OPTIMA INJECTOR N35-O (PER SITE REPORTER). BD HAS SUPPLIED US WITH BLUE CLAM SHELL CLAMPS THAT ARE SUPPOSED TO STOP THIS FROM HAPPENING. STILL HAPPENS DAILY EVEN WITH THE CLAMP. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? INFUSION. WHAT PROBLEM DID THE USER HAVE: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO. THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: CHEMOTHERAPY. DATE OF CHEMOTHERAPY: (B)(6) 2025. PRODUCT#: 515052. LOT#: 2504306. ADDITIONAL INFORMATION RECEIVED ON 23-JAN. KINDLY PROVIDE THE MATERIAL AND LOT NUMBER OF THE CONNECTOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24293006 ↗
• MalfunctionFeb 9, 2026Disconnection

  IT WAS REPORTED THAT THE INJECTOR N35-O LUER LOCK DISCONNECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 515052. BATCH # 2504306. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. DESCRIBE THE EVENT OR PROBLEM: CSTD (PHASEAL OPTIMA) INJECTOR POPPED OFF FROM THE PHASEAL OPTIMA CONNECTOR. THROUGHOUT THE SHIFT, THE RN ALSO NOTICED MULTIPLE TIMES THAT THE INJECTOR SCREW BECAME LOOSE, EVEN WITH FIRM SCREWING OF THE CONNECTOR ONTO THE IV LINES. THIS HAS HAPPENED DAILY FOR MONTHS. MANUFACTURER RESPONSE FOR OPTIMA PHASEAL, BD PHASEAL¿ OPTIMA INJECTOR N35-O (PER SITE REPORTER). BD HAS SUPPLIED US WITH BLUE CLAM SHELL CLAMPS THAT ARE SUPPOSED TO STOP THIS FROM HAPPENING. STILL HAPPENS DAILY EVEN WITH THE CLAMP. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : INFUSION. WHAT PROBLEM DID THE USER HAVE: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO. THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: CHEMOTHERAPY. DATE OF CHEMOTHERAPY: (B)(6) 2025 PRODUCT#: 515052. LOT#: 2504306. ADDITIONAL INFORMATION RECEIVED ON (B)(6). KINDLY PROVIDE THE MATERIAL AND LOT NUM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24293005 ↗
• MalfunctionFeb 5, 2026Disconnection

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24274300 ↗
• MalfunctionJan 30, 2026Leak/Splash

  PER REP'S RESPONSE: - WHAT PRODUCTS FAILED THE TEST? WAS IT THE INJECTOR ONLY? THEY TESTED INJECTOR + PROTECTOR AND INJECTOR + CONNECTOR. - WHEN PERFORMING THE TEST, HOW DID THEY GET THE PAPER UP TO THE MEMBRANE OF THE INJECTOR? NO INFORMATION AVAILABLE, THEY DID NOT SHARE TESTING DETAILS. - DO YOU KNOW IF THEY OVER PRESSURIZED THE PROTECTOR? NO INFORMATION AVAILABLE, THEY DID NOT SHARE TESTING DETAILS. - WAS THE TEAM IN GENT TRAINED ON OPTIMA? NOT RECENTLY. LAST TRAINING AND TRIAL WAS IN 2019/2020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24220776 ↗
• MalfunctionDec 2, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694888 ↗
• MalfunctionNov 18, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  EVENT DETAILS: MOISTURE WAS FOUND IN THE SEALED PACKAGE OF THE BD OPTIMA INJECTOR. PER REP: WE WERE ON SITE TODAY AND THIS WAS STORED IN A BASEMENT ROOM PRIOR TO IN-SERVICING. BUT CAN¿T BE TOTALLY SURE OF THE STORAGE CONDITIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23583445 ↗
• MalfunctionNov 11, 2025Disconnection; Leak/Splash; Disconnection; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23527011 ↗
• MalfunctionNov 6, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MAXPLUS NEEDLESS CONNECTOR WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY A CUSTOMER THAT THE LEAKING OCCURRED BETWEEN THE NEEDLELESS CONNECTOR AND THE OPTIMA CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23492896 ↗
• MalfunctionNov 6, 2025Leak/Splash; Leak/Splash

  EVENT DETAILS: PATIENT NOTED TO HAVE A CHEMO LEAK ABOUT 15ML WERE CONNECTED TO PATIENT WITH CSTD. CHECKED CONNECTION AGAIN, CLEANED PATIENT SKIN WITH SOAP AND WATER. RN THINKS THE CONNECTION BETWEEN THE CLAVE AND THE OPTIMA CONNECTOR WAS WHERE LEAK OCCURRED. ITEM: 515052.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490249 ↗
• MalfunctionNov 5, 2025Leak/Splash; Connection Problem; Leak/Splash; Connection Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23480601 ↗
• MalfunctionNov 4, 2025Leak/Splash; Leak/Splash

  EVENT DETAILS: PT WAS RECEIVING IV CELL CEPT AND CELL CEPT WAS LEAKING FROM THE PHASEAL OPTIMA, CLOSEST CONNECTION TO THE PATIENT'S CLAVE. RN TIGHTENED CONNECTION, LESS THAN 5ML LEAKED. LEAKING OCCURED BETWEEN THE NEEDLELESS CONNECTOR AND THE OPTIMA CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23467448 ↗
• MalfunctionNov 4, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23467207 ↗
• MalfunctionOct 29, 2025Leak/Splash; Leak/Splash

  EVENT DETAILS: INCIDENT DATE: (B)(6) 2025. DETAILS OF COMPLAINT (REPORTED ISSUE): DETAILS: IV TUBING WAS LEAKING AT THE CONNECTION OF THE BD PHASEAL OPTIMA AND THE BD PHASEAL OPTIMA CONNECTOR. OTHER SERIOUS OUTCOME: POTENTIAL FOR STAFF AND CLIENT EXPOSURE TO CYTOTOXIC MEDICATION. OTHER PATIENT IMPACT: EXPOSURE TO CYTOTOXIC MEDICATION OTHER ACTIONS TAKEN: INFUSION WAS COMPLETE SO IV TUBING TAKEN DOWN AND PUT IN CYTOTOXIC BIN. PLEASE NOTE: THIS COMPLAINT IS SUBMITTED FOR THE PHASEAL OPTIMA INJECTOR. SAMPLE AVAILABILITY IS UNKNOWN. COMPLAINT NOTICED: DURING / AFTER USE. PROBLEM FREQUENCY: 1ST TIME. PATIENT INJURY: NO. QTY AFFECTED: 1 EA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23413359 ↗
• MalfunctionOct 29, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  EVENT DETAILS: INJECTOR COMPLETELY FELL OFF OF DRUG TUBING; 2ND VERIFIER CHECKED ALL CONNECTIONS WERE TIGHT AT THE TIME OF INFUSION START. ITEM - 515056.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23413358 ↗
• MalfunctionOct 29, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  EVENT DETAILS: "INJECTOR FELL OFF DRUG TUBING, CAUSING CHEMO TO SPILL AND PATIENTS PORT TO BLEED". ITEM: 515056.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23413356 ↗