NA 1A8504Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00085412046167), received between May 18, 2018 and Dec 3, 2025 — classified as 50 malfunctions.

The most frequently reported specific device problem is “Break” (26 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 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SEVEN (7) 1000ML EVACUATED CONTAINERS WERE LOSING THEIR VACUUM PREMATURELY. THE PROCESS STEP DURING WHICH THIS OCCURRED WAS UNKNOWN. 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 23709712 ↗
• MalfunctionNov 13, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EVACUATED CONTAINER LEAKED IMMEDIATELY AFTER AN INTRAVENOUS (IV) SPIKE WAS INSERTED DURING THE PREPARATION OF AN IVIG (INTRAVENOUS IMMUNOGLOBULIN) INFUSION. THE VIAL STOPPER OF THE EVACUATED BOTTLE BECAME LOOSE AND DISLODGED, RESULTING IN LEAKAGE OF IVIG SOLUTION AROUND THE STOPPER AREA. 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 23550568 ↗
• MalfunctionNov 13, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EVACUATED CONTAINER LEAKED IMMEDIATELY AFTER AN INTRAVENOUS (IV) SPIKE WAS INSERTED DURING THE PREPARATION OF AN IVIG (INTRAVENOUS IMMUNOGLOBULIN) INFUSION. THE VIAL STOPPER OF THE EVACUATED BOTTLE BECAME LOOSE AND DISLODGED, RESULTING IN LEAKAGE OF IVIG SOLUTION AROUND THE STOPPER AREA. 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 23550547 ↗
• MalfunctionNov 13, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EVACUATED CONTAINER LEAKED IMMEDIATELY AFTER AN INTRAVENOUS (IV) SPIKE WAS INSERTED DURING THE PREPARATION OF AN IVIG (INTRAVENOUS IMMUNOGLOBULIN) INFUSION. THE VIAL STOPPER OF THE EVACUATED BOTTLE BECAME LOOSE AND DISLODGED, RESULTING IN LEAKAGE OF IVIG SOLUTION AROUND THE STOPPER AREA. 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 23550531 ↗
• MalfunctionOct 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE RUBBER STOPPER FELL INTO THE INTRAVENOUS IMMUNE GLOBULIN (IVIG) AND RITUXIMAB SOLUTION INSIDE OF AN 1000ML EVACUATED CONTAINER. THIS WAS OBSERVED AFTER FLUID COLLECTION. 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 23319353 ↗
• MalfunctionAug 13, 2025Break; Device Damaged Prior to Receipt by User; Break; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT ONE OF THE BOXES OF A 1000ML EVACUATED CONTAINER WAS DELIVERED BROKEN. IT WAS OBSERVED THAT THE CONTAINER WAS SHATTERED UPON RECEIVING THE DEVICE PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22798160 ↗
• MalfunctionAug 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) 1000 ML EVACUATED CONTAINERS WERE NOT MAINTAINING VACUUM DURING PROCEDURES. 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 22786917 ↗
• MalfunctionAug 7, 2025Crack; Crack

  IT WAS REPORTED THAT TWO (2) 1000ML EVACUATED CONTAINERS WERE FOUND DAMAGED (CRACKED GLASS). THIS WAS OBSERVED BEFORE USE. THE SHIPPING BOX WAS IN GOOD CONDITION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22740831 ↗
• MalfunctionJun 27, 2025Break; Break

  IT WAS REPORTED THAT ONE CASE OF 1000ML EVACUATED CONTAINERS WAS RECEIVED WITH DAMAGED PRODUCTS. THE DAMAGED PRODUCTS WERE DISCOVERED UPON DELIVERY PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346898 ↗
• MalfunctionApr 2, 2025Break; Break

  IT WAS REPORTED THAT A 1000ML EVACUATED CONTAINER WAS BROKEN. THIS WAS OBSERVED DURING A PRODUCT DELIVERY. THERE WAS NO DAMAGE OBSERVED TO THE SHIPPING CARTON. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21756059 ↗
• MalfunctionJan 17, 2025Break; Break

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF 1000 ML EVACUATED CONTAINERS WERE BROKEN. THIS ISSUE WAS FURTHER DESCRIBED AS, ¿1 CASE WAS BROKEN¿. 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 21179530 ↗
• MalfunctionDec 13, 2023Break; Break

  IT WAS REPORTED THREE (3) 1000ML EVACUATED CONTAINERS BROKE WHEN SPIKING THE CONTAINERS. THE EVENTS OCCURRED DURING AN UNKNOWN PROCESS STEP IN THE ¿ADULT INFUSION 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 18318581 ↗
• MalfunctionNov 9, 2023Break; Break

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF 1000 ML EVACUATED CONTAINERS FROM TWO (2) CASES WERE DAMAGED. THIS WAS DISCOVERED WHEN THE SHIPMENT OF THESE CONTAINERS WERE RECEIVED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18107413 ↗
• MalfunctionNov 8, 2023Break; Break

  IT WAS REPORTED THAT A 1000ML EVACUATED CONTAINER WAS DAMAGED. THE UNTIL WAS FOUND DAMAGED AFTER THE USER LOST SUCTION DURING A PROCEDURE. 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 18096905 ↗
• MalfunctionNov 8, 2023Break; Break

  IT WAS REPORTED THAT A 1000ML EVACUATED CONTAINER WAS DAMAGED. THE UNIT WAS FOUND TO HAVE BROKEN GLASS INSIDE THE BOTTLE WITH THE SEAL STILL INTACT. THIS ISSUE WAS DISCOVERED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18096869 ↗
• MalfunctionSep 5, 2023Fracture; Fracture

  IT WAS REPORTED THAT TWO (2) 1000 ML EVACUATED CONTAINERS WERE RECEIVED BROKEN (FRACTURED GLASS). THIS WAS DISCOVERED PRIOR TO USE. THE BOXES DID NOT HAVE DAMAGE ON THE OUTSIDE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17687529 ↗
• MalfunctionSep 5, 2023Break; Break

  IT WAS REPORTED THAT A 1000ML EVACUATED CONTAINER WAS DAMAGED. PRIOR TO PATIENT USE, IT WAS OBSERVED THAT THE EVACUATED GLASS CONTAINER ARRIVED SHATTERED. THE BOX THE PRODUCT ARRIVED IN WAS NOT DAMAGED BUT WHEN THE BOX WAS PICKED UP THE PRODUCT SOUNDED SHATTERED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17683910 ↗
• MalfunctionAug 31, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PLUNGER OF TWO (2) 1000 ML EVACUATED CONTAINERS FELL THROUGH WHEN SPIKING AND WERE AT THE BOTTOM OF THE BOTTLES. THIS WAS DISCOVERED SET-UP AND PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17665907 ↗
• MalfunctionJan 13, 2023Break; Break

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF 1000ML EVACUATED CONTAINERS WERE BROKEN INSIDE THE SHIPPING CONTAINER. THE SHIPPING BOX CONTAINED 6 GLASS BOTTLES AND ONE WAS BROKEN UPON ARRIVAL TO THE . 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 16159840 ↗
• MalfunctionOct 5, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE SIDE WALL OF A 1000 ML EVACUATED CONTAINER RUPTURED. THIS WAS OBSERVED WHILE THE BOTTLE WAS BEING FILLED DURING PARACENTESIS. 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 15544809 ↗
• MalfunctionOct 4, 2022Crack; Crack

  IT WAS REPORTED THAT A 1000 ML EVACUATED CONTAINER WAS BROKEN (CRACKED). THE ISSUE WAS IDENTIFIED WHEN OPENING THE BOX TO UNPACK THE CONTAINERS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15539562 ↗
• MalfunctionSep 2, 2022Break; Break

  IT WAS REPORTED THAT A 1000 ML EVACUATED CONTAINER WAS BROKEN. THE BOX WAS RECEIVED BY THE CUSTOMER WITH ONE BOTTLE BROKEN AND NO DAMAGE TO THE BOX. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15348268 ↗
• MalfunctionAug 30, 2022Crack; Crack

  IT WAS REPORTED THAT A 1000ML EVACUATED CONTAINER WAS BROKEN (CRACKED). THE ISSUE WAS IDENTIFIED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15324955 ↗
• MalfunctionMay 23, 2022Crack; Crack

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF 1000ML EVACUATED CONTAINERS WERE BROKEN. THIS ISSUE WAS IDENTIFIED WHEN THE SHIPMENT WAS RECEIVED, BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14473539 ↗
• MalfunctionMar 18, 2022Break; Break

  IT WAS REPORTED THAT AT LEAST ONE (1) 1000 ML EVACUATED CONTAINER WAS BROKEN. THE ISSUE WAS IDENTIFIED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13804864 ↗