Vial Adapter 8070117Recalls & reported problems
West Pharma. Services Il, . Ltd · Vial Adapter 13mm FLL SIL - VF · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07290108240078), received between Apr 5, 2023 and Dec 11, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Contamination” (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.
Reports received per month
Most reported problems
Device problems
- Contamination3
- Tear, Rip or Hole in Device Packaging2
- Device Damaged Prior to Use1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 11, 2025Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging
THE MANUFACTURER'S PHARMACEUTICAL CUSTOMER, AMGEN, CONTACTED THE DEVICE MANUFACTURER ON 15NOV2025 TO REPORT THAT DURING THE PROPER OPENING OF THE VIAL ADAPTER'S OUTER PLASTIC PACKAGING, IT WAS NOTICED THAT THE SEALING COVER FOIL HAD ALREADY BEEN PIERCED BEFORE BEING PEELED OFF. IT IS CURRENTLY NOT KNOWN WHETHER THE PIERCED SEALING COVER BREACHED THE STERILITY OF THE PRIMARY PACKAGING AND THIS CONFIRMATION OF THIS HAS BEEN REQUESTED. AS THE AFFECTED DEVICE WAS NOT USED BY THE PATIENT, THERE WAS NO HEALTH IMPACT TO THE END USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23778679 ↗MalfunctionOct 29, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE CUSTOMER, PFIZER CONTACTED THE DEVICE MANUFACTURER ON 30SEP2024 TO REPORT THAT DURING IN-PROCESS INSPECTION, PRIOR TO CO-PACKAGING OF THE VIAL ADAPTER DEVICE WITH MEDICINAL PRODUCT, LOT J906, THE BLISTER OF ONE (1) VIAL ADAPTER OF 315 WAS FOUND TO BE PERFORATED AT THE TYVEK. THIS DEFICIENCY WAS FOUND PRIOR TO CO-PACKAGING OF THE DEVICE WITH THE DRUG PRODUCT AND PRIOR 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 20560222 ↗MalfunctionSep 29, 2023Contamination; Contamination
ON 01SEP2023, THE CUSTOMER, SHARP CLINICAL SERVICES LLC, CONTACTED WEST PHARMA. SERVICES, IL LTD. (WEST IL), TO REPORT THAT DURING RECONSTITUTION OF A MEDICATION (SOTATERCEPT 60MG OPEN LABEL PATIENT KITS) TO BE ADMINISTERED SUBCUTANEOUSLY, A GRAY PARTICLE WAS OBSERVED WITHIN THE SOLUTION THAT COULD NOT BE DISSOLVED. AS PER PHOTO PROVIDED, THE CUSTOMER COULD NOT PRECISELY PROVIDE THE DIMENSIONS OF THE PARTICLE, STATED "PERHAPS 1-2MM". THE VIAL ADAPTER, ALONG WITH THE MEDICATION AND DILUENT, WERE INSPECTED BEFORE PREPARATION STARTED AND THERE WERE NO ISSUES OBSERVED. A REPLACEMENT PRODUCT WAS PREPARED AND ADMINISTERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17843568 ↗MalfunctionApr 5, 2023Contamination; Contamination
THE CUSTOMER CONTACTED WEST IL TO REPORT THAT DURING VISUAL INCOMING INSPECTION OF VIAL ADAPTER; THE VISUAL INSPECTION FOUND CONTAMINATION OF A FIBER WHICH WAS IN DIRECT CONTACT WITH THE VIAL ADAPTER. THIS WAS FOUND PRIOR TO PATIENT USE. THE CUSTOMER DID NOT RETURN THE DEVICE TO WEST FOR EVALUATION. HOWEVER, A PHOTOGRAPH OF THE DEVICE WAS PROVIDED TO WEST AND VISIBLE CONTAMINATION OF THE DEVICE WAS VERIFIED AS CONTAMINATION OF FIBER. IF ADDITIONAL INFORMATION IS PROVIDED, A FOLLOW UP REPORT WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16685525 ↗MalfunctionApr 5, 2023Contamination; Contamination
THE CUSTOMER CONTACTED WEST IL TO REPORT THAT DURING VISUAL INCOMING INSPECTION OF VIAL ADAPTER; THE VISUAL INSPECTION FOUND CONTAMINATION OF A HAIR WHICH WAS IN DIRECT CONTACT WITH THE VIAL ADAPTER. THIS WAS FOUND PRIOR TO PATIENT USE. THE CUSTOMER DID NOT RETURN THE DEVICE TO WEST FOR EVALUATION. HOWEVER, A PHOTOGRAPH OF THE DEVICE WAS PROVIDED TO WEST AND VISIBLE CONTAMINATION OF THE DEVICE WAS VERIFIED AS CONTAMINATION OF HAIR. IF ADDITIONAL INFORMATION IS PROVIDED, A FOLLOW UP REPORT WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16685426 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.