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Vial Adaptor 8070202Recalls & reported problems

West Pharma. Services Il, . Ltd · Vial Adapter 13mm Long w/25μm Filter- VF · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290108240245), received between Sep 26, 2023 and May 3, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination” (2 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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Contamination2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 3, 2024Contamination; Contamination

    ON (B)(6) 2024, THE CUSTOMER, NOVO NORDISK, CONTACTED WEST PHARMA. SERVICES, IL LTD. (WEST IL), TO REPORT THAT DURING THE IN PROCESS INSPECTION, PRIOR TO RELEASE TO THE MARKET OF THE VIAL ADAPTERS, A LOOSE BLACK PARTICULATE MATTER WAS OBSERVED WITHIN THE VIAL ADAPTER BLISTER PACK. THE AFFECTED LOT NUMBER INVOLVED IN THIS REPORTED EVENT IS F768.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19238381 ↗
  • MalfunctionSep 26, 2023Contamination; Contamination

    ON (B)(6) 2023, THE CUSTOMER, NOVO NORDISK, CONTACTED WEST PHARMA. SERVICES, IL LTD. (WEST IL), TO REPORT THAT DURING QUALITY CONTROL OF LOT F759, ONE (1) RETENTION SAMPLE OF THE VIAL ADAPTER 13 MM, WAS FOUND TO HAVE VISIBLE BLACK PARTICLES WITHIN THE SEAL OF THE PACKAGING AND ALSO ON THE INSIDE OF THE PACKAGED DEVICE. THE EVENT WAS DISCOVERED PRIOR TO PATIENT USE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17817781 ↗

Other Set, I.V. Fluid Transfer devices

All Set, I.V. Fluid Transfer devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.