VIAL-MATE 2B8071Recalls & reported problems

Summary

The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 00085412027388), received between Jan 29, 2018 and Sep 15, 2026 — classified as 101 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (62 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 101 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50781607 ↗
• MalfunctionSep 10, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50721042 ↗
• MalfunctionJul 21, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25892040 ↗
• MalfunctionJul 3, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT UNSPECIFIED UNITS OF VIAL MATE ADAPTERS LEAKED. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25709054 ↗
• MalfunctionDec 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A LEAK OBSERVED DURING THE USE OF A VIAL-MATE ADAPTOR. IT WAS DISCOVERED THAT THE ADAPTER WAS LEAKING INTRAVENOUS ANTIBIOTIC DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23744909 ↗
• MalfunctionSep 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKS WERE OBSERVED DURING USE OF AN UNSPECIFIED QUANTITY OF VIAL-MATE ADAPTERS. PATIENT INVOLVEMENT WAS NOT SPECIFIED; HOWEVER, THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22979495 ↗
• MalfunctionAug 8, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  WHILE ACTIVATING A VIAL-MATE ADAPTOR TO RECONSTITUTE MEDICATION, IT WAS OBSERVED THAT THE VIALMATE CORED THE STOPPER PRIOR TO TRANSFERRING RECONSTITUTED MEDICATION BACK INTO BAG AND ADMINISTERING TO PATIENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22754846 ↗
• MalfunctionAug 6, 2025Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT THERE WERE ISSUES WITH MIXING AND/OR TRANSFER OF CONTENTS TO BAGS DURING USE OF AN UNSPECIFIED QUANTITY OF VIAL-MATE ADAPTERS. THIS WAS OBSERVED POST PATIENT INFUSION WITH VANCOMYCIN 1 AND 1.5 GM INTRAVENOUS (IV) DOSES. THE DOSES WERE PREPARED USING NORMAL SALINE (NS) 250 ML BAGS. THERE WAS A CONCERN FOR LEAKAGE (BACKFLOW) FROM THE BAG BACK INTO THE EMPTY VIAL WHEN THE NS BAG WAS HUNG DURING INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730344 ↗
• MalfunctionMay 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT UNSPECIFIED QUANTITY OF VIAL-MATE ADAPTERS LEAKED. THIS OCCURRED ON THE INTENSIVE CARE UNIT (ICU) DURING INFUSION PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078666 ↗
• MalfunctionMay 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF VIAL-MATE ADAPTERS LEAKED FROM AN UNSPECIFIED LOCATION. THE PROCESS STEP WAS NOT SPECIFIED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22062472 ↗
• MalfunctionMar 18, 2025Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT AN UNSPECIFIED AMOUNT OF VIAL-MATE ADAPTERS WERE USED WITH INCOMPATIBLE BAGS. THE ADAPTERS WERE INSTRUCTED TO NOT BE USED WITH THE 250 ML BAGS OF THE IMPORTED FLUID CONTAINING 0.9% NORMAL SALINE AS THE ADAPTER COULD INTRODUCE PARTICLES INTO THE ADMIXTURE. THIS WAS MENTIONED IN THE DHCP LETTER RECEIVED BY THE USER FACILITY. HOWEVER, DURING THE INTERIM BETWEEN RECEIPT OF SHIPMENT AND RECEIPT OF THE ATTACHED LETTER, NUMEROUS BAGS WHICH INCLUDED A VIAL MATE ADAPTER WERE DISPENSED AND ADMINISTERED TO THE PATIENTS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21633588 ↗
• MalfunctionFeb 13, 2025Fluid/Blood Leak; Fitting Problem; Fluid/Blood Leak; Fitting Problem

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF VIAL-MATE ADAPTERS WERE DIFFICULT TO ATTACH TO NORMAL SALINE 250 ML BAGS WHICH RESULTED IN FLUID LEAKS. ALTHOUGH THE VIAL-MATE ADAPTERS APPEAR TO BE ATTACHED, THE NEEDLE WITHIN THE VIAL-MATE WOULD EASILY PULL OUT OF THE PORT CAUSING THE BAGS TO LEAK WHEN ACTIVATED. THE LEAKS WERE IDENTIFIED AT THE PORT WHERE THE VIAL MATE IS ATTACHED TO THE 250 ML BAG AND IT APPEARS TO BE BETWEEN THE TWO COMPONENTS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21375212 ↗
• MalfunctionJan 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A VIAL-MATE ADAPTER LEAKED AT THE ATTACHMENT TO THE VIAL. THIS OCCURRED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143241 ↗
• MalfunctionJan 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A VIAL-MATE ADAPTER LEAKED AT THE VIAL INTERFACE. THE DEVICE WAS USED TO CONNECT THE VANCOMYCIN VIAL TO THE NORMAL SALINE INTRAVENOUS FLUID BAG. THIS OCCURRED DURING PATIENT INFUSION AT THE EMERGENCY DEPARTMENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21073158 ↗
• MalfunctionNov 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A VIAL-MATE ADAPTER LEAKED FROM AN UNSPECIFIED LOCATION. THIS OCCURRED DURING SETUP PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20687462 ↗
• MalfunctionOct 28, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED LEAKS WERE OBSERVED DURING USE OF TWO (2) VIAL-MATE ADAPTERS. THIS WAS FOUND AFTER RECONSTITUTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20547416 ↗
• MalfunctionOct 23, 2024Backflow; Free or Unrestricted Flow; Backflow; Free or Unrestricted Flow

  IT WAS REPORTED THAT THERE WAS UNRESTRICTED FLUID FLOW THROUGH FOUR (4) VIAL-MATE ADAPTERS. THE VIAL-MATES WERE CONNECTED TO THE FLUID BAG, AND FLUID WAS BEING SQUEEZED INTO THE VIAL. HOWEVER, THE FLUID WAS FOUND TO BE REGURGITATING UP AND OUT OF THE TOP OF THE VIAL-MATES. SIMILARLY, WHEN HUNG ON THE HOOK, THE FLUID BACKFLOWED AND CAME OUT OF THE TOP OF THE VIAL-MATE. THIS WAS OBSERVED DURING SETUP PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20515205 ↗
• MalfunctionOct 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A VIAL-MATE ADAPTER LEAKED AROUND THE ADAPTER AND DOWN THE GLASS VIAL DURING USE. THE DEVICE CONTAINED 3G AMPICILLIN SULBACTAM. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20406760 ↗
• MalfunctionSep 11, 2024

  PT ORDERED FOR 3G AMPICILLIN SULBACTAM TO BE RECONSTITUTED USING VIAL TO BAG ADAPTER.AFTER HANGING THE MEDICATION, NOTED THE DRUG WAS LEAKING FROM AROUND THE ADAPTER AND DOWN THE GLASS VIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20189170 ↗
• MalfunctionSep 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A LEAK WAS OBSERVED DURING USE OF AT LEAST ONE (1) VIAL-MATE ADAPTER. THIS WAS NOTICED DURING INFUSION SET UP, WHEN THE BAG WAS HUNG AFTER THE MIXING WAS COMPLETED. NEW SUPPLIES WERE USED TO CONTINUE PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157539 ↗
• MalfunctionSep 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A LEAK WAS OBSERVED DURING USE OF AT LEAST ONE (1) VIAL-MATE ADAPTER. THIS WAS NOTICED DURING INFUSION SET UP, WHEN THE BAG WAS HUNG AFTER THE MIXING WAS COMPLETED. NEW SUPPLIES WERE USED TO CONTINUE PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157537 ↗
• MalfunctionSep 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A LEAK WAS OBSERVED DURING USE OF A VIAL-MATE ADAPTER; FURTHER DESCRIBED AS "LEAKING WHEN PULLED UP FULLY AND LOCKED". THIS OCCURRED WHEN THE DEVICE WAS HUNG UP DURING INFUSION SET UP. ONCE THE DEVICE WAS DISCONNECTED, THE BAG DID NOT LEAK. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20137674 ↗
• MalfunctionSep 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A LEAK WAS OBSERVED FROM AN UNSPECIFIED LOCATION DURING THE USE OF A VIAL-MATE ADAPTER. THE LEAK WAS OBSERVED DURING INFUSION SETUP AS THE DEVICE WAS SECURELY ATTACHED TO THE BAG AND VIAL, SNAPPING INTO PLACE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20135240 ↗
• MalfunctionAug 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) VIAL-MATE ADAPTER LEAKED ¿WHEN PULLED UP FULLY AND LOCKED¿. THE EVENT OCCURRED DURING AN UNKNOWN PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20075795 ↗
• MalfunctionAug 22, 2024Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT FLUID WAS LEAKING BACK INTO THE VIALS DURING USE OF AN UNSPECIFIED QUANTITY OF VIAL-MATE ADAPTERS. THIS OCCURRED DURING PREPARATION ONCE THE VIAL ACTIVATION WAS COMPLETED; THE ADAPTERS WERE CONNECTED TO SODIUM CHLORIDE BAGS AND VANCOMYCIN VIALS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20035881 ↗