Vial Adaptor 8072003Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07290108240177), received between Jul 6, 2023 and Jan 13, 2025 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2025Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  THE DEVICE MANUFACTURER'S PHARMACEUTICAL CUSTOMER, APG EUROPE, CONTACTED THE DEVICE MANUFACTURER TO REPORT PACKAGING DAMAGE. ON 16DEC2024, APG EUROPE PROVIDED ADDITIONAL DETAILS AND PHOTOS SHOWING THAT PACKAGING DAMAGE RESULTED IN BREACH OF STERILITY OF THE DEVICE. THIS DEFICIENCY WAS FOUND PRIOR TO USE. THE DEVICE HAD NOT YET ENTERED INTO THE DISTRIBUTION STAGE TO THE END USER (I.E. BEING PUT INTO SERVICE), THERE WAS NO HEALTH IMPACT TO THE END USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21141205 ↗
• MalfunctionAug 22, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  ON (B)(6) 2023, BAYER, CONTACTED WEST PHARMACEUTICAL SERVICES, INC. (WEST), TO REPORT THAT DURING INCOMING INSPECTION OF THE WEST IL, VIAL ADAPTER, LOT H666, 1 OF 500 PRODUCTS HAS A VISIBLE INCOMPLETE BLISTER SEAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597321 ↗
• InjuryJul 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER, PACIRA BIOSCIENCES, INC., INITIALLY CONTACTED WEST IL ON (B)(6) 2023 TO REPORT THAT FOUR PATIENTS DEVELOPED INFECTIONS POST INJECTION OF THE MEDICATION ZILRETTA, TO THE KNEE JOINT. SUBSEQUENTLY, THE CUSTOMER REPORTED AN ADDITIONAL TWO PATIENTS ON (B)(6) 2023 WHO ALSO DEVELOPED INFECTIONS POST INJECTION OF THE MEDICATION ZILRETTA, TO THE KNEE JOINT. THEREFORE, A TOTAL OF SIX PATIENTS WERE REPORTED. THERE WERE THREE DIFFERENT HEALTHCARE FACILITIES INVOLVED IN ALL SIX EVENTS. THE FACILITY WHERE THIS EVENT TOOK PLACE WAS IN ARKANSAS, UNITED STATES OF AMERICA. HOWEVER, THE NAME OF THE FACILITY WAS NOT PROVIDED. THE DATE OF EVENT AND THE ONSET OF INFECTION IS UNKNOWN FOR THIS INCIDENT. THIS REPORT IS FOR PATIENT FOUR OF SIX. ZILRETTA IS A SINGLE DOSE MEDICATION PACKAGED AS A KIT WITH THE WEST IL VIAL ADAPTER 20MM FLL -VF UNIVERSAL. PER THE CUSTOMER, ALL KITS USED ON THE SIX PATIENTS WHO DEVELOPED INFECTIONS, CONTAINED THE SAME WEST IL VIAL ADAPTER (LOT# E891). HOWEVER, THESE KITS ARE PACKAGED WITH THE ZILRETTA MEDICATION AND A DILUENT. THE DRUG PRODUCT AND DILUENT ARE OF DIFFERENT LOTS. THERE WAS NO REPORT OF BREACH IN STERILITY AND THE INJECTION WAS ADMINISTERED UNEVENTFUL

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 17269369 ↗
• InjuryJul 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER, (B)(6)., INITIALLY CONTACTED WEST IL ON 09JUN2023 TO REPORT THAT FOUR PATIENTS DEVELOPED INFECTIONS POST INJECTION OF THE MEDICATION ZILRETTA, TO THE KNEE JOINT. SUBSEQUENTLY, THE CUSTOMER REPORTED AN ADDITIONAL TWO PATIENTS ON 14JUN2023 WHO ALSO DEVELOPED INFECTIONS POST INJECTION OF THE MEDICATION ZILRETTA, TO THE KNEE JOINT. THEREFORE, A TOTAL OF SIX PATIENTS WERE REPORTED. THERE WERE THREE DIFFERENT HEALTHCARE FACILITIES INVOLVED IN ALL SIX EVENTS. THE FACILITY WHERE THIS EVENT TOOK PLACE WAS IN (B)(6), UNITED STATES OF AMERICA. HOWEVER, THE NAME OF THE FACILITY WAS NOT PROVIDED. THE DATE OF EVENT AND THE ONSET OF INFECTION IS UNKNOWN FOR THIS INCIDENT. THIS REPORT IS FOR PATIENT THREE OF SIX. ZILRETTA IS A SINGLE DOSE MEDICATION PACKAGED AS A KIT WITH THE WEST IL VIAL ADAPTER 20MM FLL -VF UNIVERSAL. PER THE CUSTOMER, ALL KITS USED ON THE SIX PATIENTS WHO DEVELOPED INFECTIONS, CONTAINED THE SAME WEST IL VIAL ADAPTER (LOT# E891). HOWEVER, THESE KITS ARE PACKAGED WITH THE ZILRETTA MEDICATION AND A DILUENT. THE DRUG PRODUCT AND DILUENT ARE OF DIFFERENT LOTS. THERE WAS NO REPORT OF BREACH IN STERILITY AND THE INJECTION WAS ADMINISTERED UNEVENTFULLY. THE PATIENT WAS TR

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 17269365 ↗
• InjuryJul 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER, PACIRA BIOSCIENCES, INC., INITIALLY CONTACTED WEST IL ON 09JUN2023 TO REPORT THAT FOUR PATIENTS DEVELOPED INFECTIONS POST INJECTION OF THE MEDICATION ZILRETTA, TO THE KNEE JOINT. SUBSEQUENTLY, THE CUSTOMER REPORTED AN ADDITIONAL TWO PATIENTS ON (B)(6) 2023 WHO ALSO DEVELOPED INFECTIONS POST INJECTION OF THE MEDICATION ZILRETTA, TO THE KNEE JOINT. THEREFORE, A TOTAL OF SIX PATIENTS WERE REPORTED. THERE WERE THREE DIFFERENT HEALTHCARE FACILITIES INVOLVED IN ALL SIX EVENTS. THE FACILITY WHERE THIS EVENT TOOK PLACE WAS IN MISSOURI, UNITED STATES OF AMERICA. HOWEVER, THE NAME OF THE FACILITY WAS NOT PROVIDED. THE DATE OF EVENT AND THE ONSET OF INFECTION IS UNKNOWN FOR THIS INCIDENT. THIS REPORT IS FOR PATIENT TWO OF SIX. ZILRETTA IS A SINGLE DOSE MEDICATION PACKAGED AS A KIT WITH THE WEST IL VIAL ADAPTER 20MM FLL -VF UNIVERSAL. PER THE CUSTOMER, ALL KITS USED ON THE SIX PATIENTS WHO DEVELOPED INFECTIONS, CONTAINED THE SAME WEST IL VIAL ADAPTER (LOT# E891). HOWEVER, THESE KITS ARE PACKAGED WITH THE ZILRETTA MEDICATION AND A DILUENT. THE DRUG PRODUCT AND DILUENT ARE OF DIFFERENT LOTS. THERE WAS NO REPORT OF BREACH IN STERILITY AND THE INJECTION WAS ADMINISTERED UNEVENTFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 17269351 ↗
• InjuryJul 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER, PACIRA BIOSCIENCES, INC., INITIALLY CONTACTED WEST IL ON 09JUN2023 TO REPORT THAT FOUR PATIENTS DEVELOPED INFECTIONS POST INJECTION OF THE MEDICATION ZILRETTA, TO THE KNEE JOINT. SUBSEQUENTLY, THE CUSTOMER REPORTED AN ADDITIONAL TWO PATIENTS ON (B)(6) 2023 WHO ALSO DEVELOPED INFECTIONS POST INJECTION OF THE MEDICATION ZILRETTA, TO THE KNEE JOINT. THEREFORE, A TOTAL OF SIX PATIENTS WERE REPORTED. THERE WERE THREE DIFFERENT HEALTHCARE FACILITIES INVOLVED IN ALL SIX EVENTS. THE FACILITY WHERE THIS EVENT TOOK PLACE WAS IN WASHINGTON, PENNSYLVANIA IN THE UNITED STATES OF AMERICA. HOWEVER, THE NAME OF THE FACILITY WAS NOT PROVIDED. THE DATE OF EVENT AND THE ONSET OF INFECTION IS UNKNOWN FOR THIS INCIDENT. THIS REPORT IS FOR PATIENT SIX OF SIX.. ZILRETTA IS A SINGLE DOSE MEDICATION PACKAGED AS A KIT WITH THE WEST IL VIAL ADAPTER 20MM FLL -VF UNIVERSAL. PER THE CUSTOMER, ALL KITS USED ON THE SIX PATIENTS WHO DEVELOPED INFECTIONS, CONTAINED THE SAME WEST IL VIAL ADAPTER (LOT# E891). HOWEVER, THESE KITS ARE PACKAGED WITH THE ZILRETTA MEDICATION AND A DILUENT. THE DRUG PRODUCT AND DILUENT ARE OF DIFFERENT LOTS. THERE WAS NO REPORT OF BREACH IN STERILITY AND THE INJECTION WAS ADM

  Patient problems: Unspecified Infection

  MAUDE report 17269318 ↗
• InjuryJul 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER, PACIRA BIOSCIENCES, INC., INITIALLY CONTACTED WEST IL ON 09JUN2023 TO REPORT THAT FOUR PATIENTS DEVELOPED INFECTIONS POST INJECTION OF THE MEDICATION ZILRETTA, TO THE KNEE JOINT. SUBSEQUENTLY, THE CUSTOMER REPORTED AN ADDITIONAL TWO PATIENTS ON (B)(6) 2023 WHO ALSO DEVELOPED INFECTIONS POST INJECTION OF THE MEDICATION ZILRETTA, TO THE KNEE JOINT. THEREFORE, A TOTAL OF SIX PATIENTS WERE REPORTED. THERE WERE THREE DIFFERENT HEALTHCARE FACILITIES INVOLVED IN ALL SIX EVENTS. THE FACILITY WHERE THIS EVENT TOOK PLACE WAS IN ARKANSAS, UNITED STATES OF AMERICA. HOWEVER, THE NAME OF THE FACILITY WAS NOT PROVIDED. THE DATE OF EVENT AND THE ONSET OF INFECTION IS UNKNOWN FOR THIS INCIDENT. THIS REPORT IS FOR PATIENT FIVE OF SIX. ZILRETTA IS A SINGLE DOSE MEDICATION PACKAGED AS A KIT WITH THE WEST IL VIAL ADAPTER 20MM FLL -VF UNIVERSAL. PER THE CUSTOMER, ALL KITS USED ON THE SIX PATIENTS WHO DEVELOPED INFECTIONS, CONTAINED THE SAME WEST IL VIAL ADAPTER (LOT# E891). HOWEVER, THESE KITS ARE PACKAGED WITH THE ZILRETTA MEDICATION AND A DILUENT. THE DRUG PRODUCT AND DILUENT ARE OF DIFFERENT LOTS. THERE WAS NO REPORT OF BREACH IN STERILITY AND THE INJECTION WAS ADMINISTERED UNEVENTFULLY

  Patient problems: Unspecified Infection

  MAUDE report 17269313 ↗
• InjuryJul 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER, PACIRA BIOSCIENCES, INC., INITIALLY CONTACTED WEST IL ON (B)(6) 2023 TO REPORT THAT FOUR PATIENTS DEVELOPED INFECTIONS POST INJECTION OF THE MEDICATION ZILRETTA, TO THE KNEE JOINT. SUBSEQUENTLY, THE CUSTOMER REPORTED AN ADDITIONAL TWO PATIENTS ON (B)(6) 2023 WHO ALSO DEVELOPED INFECTIONS POST INJECTION OF THE MEDICATION ZILRETTA, TO THE KNEE JOINT. THEREFORE, A TOTAL OF SIX PATIENTS WERE REPORTED. THERE WERE THREE DIFFERENT HEALTHCARE FACILITIES INVOLVED IN ALL SIX EVENTS. THE FACILITY WHERE THIS EVENT TOOK PLACE WAS IN MISSOURI, UNITED STATES OF AMERICA. HOWEVER, THE NAME OF THE FACILITY WAS NOT PROVIDED. THE DATE OF EVENT AND THE ONSET OF INFECTION IS UNKNOWN FOR THIS INCIDENT. THIS REPORT IS FOR PATIENT ONE OF SIX. ZILRETTA IS A SINGLE DOSE MEDICATION PACKAGED AS A KIT WITH THE WEST IL VIAL ADAPTER 20MM FLL -VF UNIVERSAL. PER THE CUSTOMER, ALL KITS USED ON THE SIX PATIENTS WHO DEVELOPED INFECTIONS, CONTAINED THE SAME WEST IL VIAL ADAPTER (LOT# E891). HOWEVER, THESE KITS ARE PACKAGED WITH THE ZILRETTA MEDICATION AND A DILUENT. THE DRUG PRODUCT AND DILUENT ARE OF DIFFERENT LOTS. THERE WAS NO REPORT OF BREACH IN STERILITY AND THE INJECTION WAS ADMINISTERED UNEVENTFULL

  Patient problems: Unspecified Infection

  MAUDE report 17269275 ↗