Vial Adaptor 8072045Recalls & reported problems
West Pharma. Services Il, . Ltd · Vial Adapter 20mm FLL w/ Ribs - VF · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290108240412), received between Jun 12, 2024 and Jun 12, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination” (1 report).
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
- Contamination1
- Contamination /Decontamination Problem1
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2024Contamination; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Contamination; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping
ON 13MAY2024, THE CUSTOMER, FERRING PHARMACEUTICALS, CONTACTED WEST PHARMA. SERVICES, IL LTD. (WEST IL), TO REPORT THAT DURING ASSEMBLY OF FERRING'S COMBINATION PACK, A VIAL ADAPTER, WAS OBSERVED WITH A BLUE FOREIGN PARTICULATE MATTER WITHIN THE PRIMARY STERILE PACKAGE. SUBSEQUENTLY, THE CUSTOMER OBSERVED A SECOND VIAL ADAPTER WITH ANOTHER BLUE FOREIGN PARTICULATE MATTER WITHIN THE PRIMARY STERILE PACKAGE. BOTH VIAL ADAPTERS ARE FROM LOT # F700. THE WEST PHARMA. VIAL ADAPTERS ARE CO-PACKED WITH THE DRUG FIRMAGON, THIS MEDICATION IS TO BE ADMINISTERED SUBCUTANEOUSLY AS AN INJECTION. BATCH RECORDS FOR LOT# F700 WERE REVIEWED AND THERE WERE NO NON CONFORMANCES FOUND. QUALITY CONTROL INSPECTIONS WERE CONDUCTED ACCORDING TO PROCEDURES DURING PRODUCTION, NO ISSUES WERE NOTICED. THE INCOMING INSPECTION RECORDS OF THE TYVEK AND NEEDLES WERE REVIEWED, NO ISSUES WERE NOTICED. LOT #F700 WAS MANUFACTURED ACCORDING TO RELEVANT PROCEDURES TESTED BEFORE RELEASE AND SHIPPED ACCORDING TO SPECIFICATIONS. RETAINED SAMPLES FROM LOT #F700 WERE 100% VISUALLY INSPECTED BY THE CONTRACT MANUFACTURER ACCORDING TO THEIR INTERNAL PROCEDURE, NO FINDINGS WERE OBSERVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19520328 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.