Equashield Equashield Female Luer Lock ConnectorRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07290013484536), received between Nov 12, 2020 and Mar 12, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 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 16, 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.

• MalfunctionMar 12, 2026

  HOOKING UP FEMALE EQUASHIELD TO A FLUSH TO PREPARE TO GIVE CHEMO. CHECKING SWIVEL TO ENSURE PROPER ATTACHMENT AND THE FLUSH CAME OFF. UNSURE OF WHETHER THE FLUSH OR THE FEMALE EQUASHIELD WAS AT FAULT, HAD CHARGE NURSE COME ATTACH TWO PIECES TOGETHER AND HAD THE SAME ISSUE. EACH TIME CONNECTING THIS FLUSH WITH EQUASHIELD THE FLUSH WAS BECOMING DETACHED DESPITE TRIPLE CHECKING THE SWIVEL. THIS MADE THIS FLUSH AND EQUASHIELD NOT SUITABLE TO GIVE CHEMO THROUGH AND ANOTHER FLUSH AND EQUASHIELD HAD TO BE USED TO ACHIEVE PROPER SAFETY FEATURES WHEN GIVING CHEMO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24579033 ↗
• MalfunctionJun 24, 2025Fluid/Blood Leak; Detachment of Device or Device Component

  AT APPROXIMATELY 1556, CALL LIGHT WAS PRESSED AND NURSING STAFF ENTERED ROOM TO ETOPOSIDE LINE UNHOOKED AT THE FEMALE EQUASHIELD AND TUBING CONNECTION AND DRIPPING BLOOD ONTO THE BED. PER RN REPORT, PRIOR TO STARTING THE MEDICATION, 2 RNS ENSURED THAT SWIVEL COLLAR ON TUBING WAS PULLED BACK, TUBING WAS SECURED INTO EQUASHIELD AND THEN COLLAR WAS PULLED DOWN AND TIGHTENED. MANUFACTURER RESPONSE FOR CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM, EQUASHIELD (PER SITE REPORTER). THEY ARE SENDING A CANNISTER TO HAVE THE DEVICE SHIPPED TO THEM FOR TESTING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22318157 ↗
• MalfunctionJun 2, 2025Contamination; Detachment of Device or Device Component

  CHEMOTHERAPY LINE INFUSING. DOUBLE CHECKED BY SECOND RN. EQUASHIELD DEVICE CAME UNSCREWED FROM LINE DESPITE ENSURING IT WAS ON TIGHT. SAFETY CHECKS HAD BEEN COMPLETED FOR THE LINE AND HAD BEEN DOUBLE CHECKED BY A SECOND RN. THIS CAUSED A CHEMO SPILL. SAFETY PROTOCOLS FOLLOWED. CHEMO SPILL GUIDELINES FOLLOWED. MANUFACTURER RESPONSE FOR CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM, EQUASHIELD (PER SITE REPORTER). REQUESTED DEVICE AND ALL TUBING BE SENT TO THEM FOR TESTING. CURRENTLY AWAITING THEIR SHIPPING CONTAINER. DEVICE WILL THEN BE SENT BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22122439 ↗
• MalfunctionApr 30, 2025Fluid/Blood Leak; Failure to Deliver; Connection Problem

  THIS RN WALKED IN TO THE PATIENT'S ROOM AROUND 2100 TO GIVE AN AS NEEDED MEDICATION AND FOUND THE PATIENT'S CHEMOTHERAPY DRIPPING ON TO THE FLOOR. UPON FURTHER ASSESSMENT, THIS RN NOTED THE PATIENT'S CHEMOTHERAPY TUBING WAS DISCONNECTED AT THE SWIVEL PART OF THE FEMALE EQUASHIELD PIECE. MANUFACTURER RESPONSE FOR CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM, EQUASHIELD (PER SITE REPORTER). REQUESTED DEVICE SENT BACK TO THEM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21933494 ↗
• MalfunctionApr 3, 2025

  WHEN SETTING UP CHEMO TUBING, PUT ON EQUASHIELD FEMALE SWIVEL CONNECTOR, VERIFIED IT WAS ENGAGED AND SWIVELED WITHOUT BEING ABLE TO COME OFF TUBING. THEN STARTED CHEMO. WHILE CHEMO WAS INFUSING, EQUASHIELD FC-1S DEVICE CAME OFF THE END OF THE IV TUBING RESULTING IN A SPILL AND NEED TO MAKE NEW BAG OF CHEMO. MANUFACTURER RESPONSE FOR CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM, EQUASHIELD (PER SITE REPORTER). REQUESTED WE MAIL IT TO THEM FOR TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21761138 ↗
• MalfunctionMar 10, 2025

  EQUASHIELD MALFUNCTIONED. ABLE TO CIRCLE PRIME AND PUT ON PUMP. WHEN I WENT TO ATTACH VINCRISTINE TO THE PATIENT THROUGH THE FEMALE ADAPTOR, THE FEMALE CONNETOR (FC-1S) CAME COMLETELY OFF. VINCRISTINE SPILLED FROM BAG AND TUBING. NEW BAG OF VINCRISTINE HAD TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558822 ↗
• MalfunctionJan 28, 2025

  REGISTERED NURSE (RN) WAS CALLED INTO PATIENT'S ROOM AND PATIENT'S MOM STATED, "I THINK SOMETHING MIGHT BE LEAKING". UPON ASSESSMENT, RN NOTED PATIENT'S CHEMOTHERAPY (CHEMO) TUBING LYING IN THE BED UNHOOKED FROM EQUASHIELD FEMALE SWIVEL CONNECTOR. BLOOD WAS BACKFLOWING INTO THE EQUASHIELD AND ONTO THE BED FROM PATIENT'S PORT. MINIMAL AMOUNT OF DRAINAGE NOTED. CHEMO LINE STOPPED/CLAMPED. PORT TUBING CLAMPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21251446 ↗
• MalfunctionJan 15, 2025

  MOTHER WALKED OUT OF ROOM AND SAID TUBING HAD COME DISCONNECTED WHEN THEY SET PATIENT ON THE FLOOR TO PLAY. I WALKED IN AND IMMEDIATELY PAUSED THE CHEMOTHERAPY (CHEMO) CHANNEL THAT WAS INFUSING 24 HOUR CYTARABINE. 3 DROPS OF CHEMO LIQUID WERE NOTED ON PLAYMAT AND WAS WIPED UP. EQUASHIELD FEMALE AND MALE PIECE STILL ATTACHED TO CLAVE ON PATIENT'S PORT WITH BLOOD BACKED UP AND STARTING TO COME OUT OF EQUASHIELD PIECES. TUBING HAD COME UNATTACHED FROM SWIVEL CONNECTOR THAT LUER LOCKS ON AND SHOULDN'T BE ABLE TO BE DISCONNECTED. I HAD STARTED THE CHEMO THE DAY BEFORE AND TWISTED THIS PIECE AROUND TO ENSURE THAT IT WAS SECURELY IN PLACE.

  Patient problems: Chemical Exposure; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21158053 ↗
• MalfunctionNov 12, 2020Leak/Splash

  LEAKING AT THE CONNECTOR SITE.

  Patient problems: Insufficient Information

  MAUDE report 10830307 ↗
• MalfunctionNov 12, 2020Leak/Splash

  FEMALE LUER LOCK CONNECTOR SWIVEL - LEAKING.

  Patient problems: Insufficient Information

  MAUDE report 10828820 ↗
• MalfunctionNov 12, 2020Leak/Splash

  LEAKING NOTED FROM THE FEMALE LUER LOCK CONNECTOR SWIVEL.

  Patient problems: Insufficient Information

  MAUDE report 10828818 ↗
• MalfunctionNov 12, 2020Leak/Splash

  LEAKING AT THE FEMALE LL CONNECTOR SWIVEL DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 10828742 ↗