BD PhaSeal™ Optima Infusion Clamp M25-O 515085Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00382905150852), received between Jan 2, 2020 and Jul 21, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2025Defective Component; Free or Unrestricted Flow; Defective Component; Free or Unrestricted Flow

  ADDITIONAL INFORMATION PLEASE SHARE THE MATERIAL & LOT NUMBER ASSOCIATED WITH REPORTED ISSUE WE DO NOT HAVE THE SPECIFIC LOT NUMBER FOR THE ASSOCIATED CLAMPS SAMPLE AVAILABLE IS MENTIONED AS YES, PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL PLEASE SHIP THE RETURN LABEL TO (B)(6) AT WHAT POINT DID THIS FAILURE OCCUR? BEGINNING STAGE, THEY WOULD NOT CLAMP AROUND THE PATIENTS CONNECTION SITE, LEADING US TO HAVE TO GET A NEW CLAMP WHAT WAS THE MEDICATION TYPE AND DURATION OF THE INFUSION? IT WAS A MULTITUDE OF DIFFERENT MEDICATIONS AS THE COLLECTION OF CLAMPS IS UPWARD 10 DID THE PATIENT RECEIVE A COMBINATION OF ANY MEDICATIONS? UNAWARE, AND THE CLAMP WASN¿T IN USE AS WE HAD TO USE ANOTHER ONE, BUT THIS WAS ON MULTIPLE DIFFERENT PATIENTS WHAT PRODUCT WAS THE SET CONNECTED TO? SOME WERE PUMPS, SOME WERE LINES AND SOME WERE DIRECT TO HUBER NEEDLE HOW LONG HAS THIS PRODUCT BEEN USED IN YOUR FACILITY? SINCE MARCH WAS THERE ANY LEAK? THERE IS NO LEAK, THESE ARE INFUSION CLAMPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22560709 ↗
• MalfunctionOct 10, 2024Disconnection; Disconnection

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20416766 ↗
• MalfunctionJul 9, 2024Disconnection; Disconnection

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19700251 ↗
• MalfunctionMar 31, 2022Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED WHILE USING BD PHASEAL OPTIMA INFUSION CLAMP (M25-O) COMPONENT SEPARATION LED TO LEAKAGE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:   IT WAS REPORTED BY THE CONSUMER THE PHASEAL CAME APART DURING A CHEMO INJECTION.   NURSE SAID THAT SHE WAS TOLD THE PHASEAL COMPONENTRY CAME APART AND THAT THE PATIENT WAS SUPPOSEDLY EXPOSED TO CHEMO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13965572 ↗
• MalfunctionNov 4, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT WHEN USING THE BD PHASEAL¿ OPTIMA INFUSION CLAMP M25-O THE CLAMP WAS NOT WORKING CORRECTLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT THE CLAMP WAS NOT WORKING AS PER PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12755274 ↗
• MalfunctionSep 30, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ OPTIMA INFUSION CLAMP (M25-O) UNCLAMPED FROM THE INJECTOR, WHICH THEN SEPARATED FROM THE CONNECTOR AFTER THE PROTON PUMP THERAPY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PT ARRIVED WITH CADD PUMP DISCONNECTED. PT STATED THE BLUE OPTIMA OUTER CAP UNCLAMPED AND THE OPTIMA INJECTOR POPPED OFF FROM THE OPTIMA CONNECTOR WHEN HE GOT HOME FROM PROTON PUMP THERAPY EARLIER TODAY. ON ARRIVAL TO ATC, RN FLUSHED THE PATIENT'S PICC LINE WITH NO TROUBLE OR RESISTANCE. RN REPLACED OPTIMA CONNECTOR, TIGHTENED CONNECTIONS AND PLACED A NEW BLUE OPTIMA OUTER CAP. INFUSION RESTARTED ATER RECONNECTING TO PATIENT. RN MONITORED PT FOR 15 MINUTES AFTER RECONNECTION- NO PUMP PROBLEMS AT THIS TIME. RN REEDUCATED PT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12558079 ↗
• MalfunctionSep 3, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT CONNECTOR C35-O SEPARATED FROM THE INJECTOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE CONNECTION BETWEEN THE INJECTOR AND CONNECTOR HAD SEPARATED WHILE CHEMOTHERAPY WAS INFUSING. VERBATIM: RN TRACED LINE DUE TO "OCCLUSION" ALARM ON ALARIS PUMP FOR CYTARABINE INFUSION. RN DISCOVERED THAT THE CONNECTION BETWEEN THE INJECTOR AND CONNECTOR HAD SEPARATED WHILE CHEMOTHERAPY WAS INFUSING, PROMPTING THE PUMP TO ALARM. THIS IS DESPITE HAVING A BLUE CLAMP IN PLACE. THIS HAS HAPPENED MULTIPLE TIMES THIS ADMISSION FOR THIS PATIENT WHICH IS CONCERNING. DISCUSSED USE WITH RN WHICH SEEMS APPROPRIATE-NO NURSING ISSUES IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422462 ↗
• MalfunctionSep 2, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT CONNECTOR C35-O WAS LOOSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED: INJECTOR/CONNECTOR SEPARATION, DISCONNECTION".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12416598 ↗
• MalfunctionAug 26, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT M25-O INFUSION CLAMP MATING COMPONENTS SEPARATED AND LEAKED. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE INJECTOR AND CONNECTOR BECOME DISCONNECTED CAUSING VIOLENT ERUPTION AND FLOW ISSUES. PER EMAIL: SEE BELOW FOR TWO QUALITY INCIDENTS THAT HAVE BEEN OCCURRING FREQUENTLY. N40 AND CONNECTOR WHEN ATTACHED AN PRESSURE IS APPLIED TO N40 IT CAUSES A VIOLENT ERUPTION AND THE CONNECTOR BECOMES DISPLACED 3-5' ACROSS ROOM N40 AND CONNECTOR ARE COMING DISENGAGED WHEN BLUE CLAMP M25-0 IS PROPERLY ENGAGED. THE DISENGAGEMENT CAUSES THE IV PUMP TO STOP FLOWING AND OCCLUSION ALARMS, THUS DISRUPTING WORKFLOW AND DISTURBING PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12375191 ↗
• MalfunctionMay 13, 2021Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT WHILE USING BD PHASEAL¿ OPTIMA INFUSION CLAMP M25-O THE CLAMPS ARE NOT SNAPPING CLOSED. THIS OCCURRED WITH 10 CLAMPS. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT MANY OF THE INFUSION CLAMPS ARE NOT SNAPPING CLOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11823075 ↗
• MalfunctionMay 18, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD PHASEAL¿ OPTIMA INFUSION CLAMP (M25-O) WOULDN'T CLAMP DURING USE. THIS OCCURRED ON 7 SEPARATE OCCASIONS, BUT THE DATES AND/OR PATIENT INFORMATION ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WAS SPEAKING WITH ONE OF OUR ATC NURSES TODAY AND SHE REPORTED RECENT ISSUES WITH SOME OF THE BLUE CLAMPS NOT CLAMPING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10066972 ↗
• MalfunctionJan 2, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE INFUSION CLAMPS WERE NOT FUNCTIONING WITH A BD PHASEAL¿ INFUSION CLAMP M25. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE INFUSION CLAMPS WOULD NOT CLICK INTO PLACE OR CLOSE PROPERLY AND THAT THE TAB WOULD NOT LOCK INTO PLACE. ADDITIONALLY, THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: I WANTED TO REPORT AN ISSUE THAT TOOK PLACE TODAY WITH SEVERAL INFUSION CLAMPS WHILE AT EMORY. OUT OF 3 BOXES OF 25, SEVERAL OF THEM WOULD NOT "CLICK" INTO PLACE OR CLOSE AS THEY SHOULD, THE SMALL TAB THAT LOCKS THE 2 SIDES TOGETHER WOULDN'T LOCK. OUT OF 3 BOXES, I WOULD GUESS UP TO ~ 30% OF THE SAMPLES HAD THIS ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9539635 ↗