EXACTAMIX H93884Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00085412476827), received between Jun 22, 2020 and Nov 28, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 28, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT INLET OF SEVENTEEN (17) LUER LOCK-TO-BAG-ADAPTERS WERE OBSTRUCTED WHICH RESULTED IN RESTRICTED FLUID FLOW. THIS ISSUE WAS FURTHER DESCRIBED AS, ¿THE LUER ADAPTER END IS NOT PUNCHED OUT WHICH PREVENTS THE FLOW OF LIQUID THROUGH THE BAG ADAPTER¿ AND ¿THE CONNECTION OF THE LUER-TO-BAG ADAPTER TO THE ADDITIVE PORT DURING PRODUCTION WOULD NOT FLOW¿. THIS ISSUE WAS OBSERVED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18221585 ↗
• MalfunctionAug 29, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT THERE WAS A TRANSLUCENT MEMBRANE INSIDE A LUER LOCK-TO-BAG-ADAPTER INTERNAL THREAD LOCATED WHERE THE LUER LOCK ADAPTER AND BAG ADAPTER ARE CONNECTED. THIS WAS IDENTIFIED DURING COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17641295 ↗
• MalfunctionAug 24, 2023Obstruction of Flow; Device Contamination with Chemical or Other Material; Obstruction of Flow; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT SIX (6) EXACTAMIX ADAPTERS HAD A SMALL PIECE OF PLASTIC PREVENTING FLUID FROM FLOWING THROUGH; SOME OF THE ADAPTERS APPEARED TO BE PARTIALLY BLOCKED. THIS WAS OBSERVED DURING USE OF THE DEVICES WITH THE REPEATER PUMP AND TUBING SETS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17619353 ↗
• MalfunctionOct 19, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A PARTICLE WAS OBSERVED IN THE STERILE PACKAGING OF A LUER LOCK-TO-BAG-ADAPTER. THE ISSUE WAS IDENTIFIED BEFORE USE; DURING THE PRE-COMPOUNDING CHECK PRIOR TO OPENING THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15635911 ↗
• MalfunctionSep 13, 2022Contamination; Contamination

  IT WAS REPORTED THAT THE PACKAGING OF AN UNSPECIFIED QUANTITY OF LUER LOCK-TO-BAG-ADAPTERS INTERNAL THREAD WAS DAMAGED; FURTHER DESCRIBED AS "LOOKS TRANSPARENT AND AIR IS NOW EASILY ESCAPING THE PACKAGE."THIS WAS OBSERVED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15412003 ↗
• MalfunctionMar 25, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A LUER LOCK-TO-BAG-ADAPTER INTERNAL THREAD HAD A HAIR IN THE PACKAGING. THIS ISSUE WAS IDENTIFIED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11569210 ↗
• MalfunctionJun 22, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED AN UNSPECIFIED QUANTITY OF LUER LOCK-TO-BAG-ADAPTER INTERNAL THREAD WAS CONTAMINATED. IT WAS FURTHER SPECIFIED THAT THE PACKAGING WAS WET. THIS ISSUES WAS IDENTIFIED DURING SETUP AND PREPARATION THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10179569 ↗