Swabable Vial Adapter 8070101Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07290108240498), received between Mar 4, 2025 and Sep 24, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Contamination” (13 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Contamination /Decontamination Problem

  The customer, Dompe farmaceutici SpA, contacted the device manufacturer on 25Aug26 to report during packaging of the Swabable Vial Adapter (SVA) with the customer's drug product, foreign particles were detected within the primary packaging of the devices and also within the sealing area of the primary packaging. 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 50882976 ↗
• MalfunctionJul 29, 2026Contamination; Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50069903 ↗
• MalfunctionJun 16, 2026Contamination

  THE CUSTOMER, DOMPE FARMACEUTICI SPA, CONTACTED THE DEVICE MANUFACTURER ON 21MAY2026 TO REPORT THAT DURING PACKAGING OF THE SWABABLE VIAL ADAPTER (SVA) WITH THE CUSTOMER'S DRUG PRODUCT, FOREIGN PARTICLES WERE DETECTED WITHIN THE PRIMARY PACKAGING OF THE DEVICES AND ALSO WITHIN THE SEALING AREA OF THE PRIMARY PACKAGING. THIS DEFICIENCY WAS FOUND PRIOR TO USE. AS 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 25519773 ↗
• MalfunctionJun 10, 2026Contamination; Contamination /Decontamination Problem

  THE CUSTOMER, (B)(6), CONTACTED THE DEVICE MANUFACTURER ON 06MAY2026 TO REPORT DURING PACKAGING OF THE SWABABLE VIAL ADAPTER (SVA) WITH THE CUSTOMER'S DRUG PRODUCT, FOREIGN PARTICLES WERE DETECTED WITHIN THE PRIMARY PACKAGING OF THE DEVICES AND ALSO WITHIN THE SEALING AREA OF THE PRIMARY PACKAGING. 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 25457700 ↗
• MalfunctionMay 19, 2026Contamination; Contamination /Decontamination Problem

  THE CUSTOMER, DOMPE FARMACEUTICI SPA, CONTACTED THE DEVICE MANUFACTURER ON 22APR2026 TO REPORT DURING PACKAGING OF THE SWABABLE VIAL ADAPTER (SVA) WITH THE CUSTOMER'S DRUG PRODUCT, FOREIGN PARTICLES WERE DETECTED WITHIN THE PRIMARY PACKAGING OF THE DEVICES AND ALSO WITHIN THE SEALING AREA OF THE PRIMARY PACKAGING. THE CUSTOMER CONFIRMED THAT THE AFFECTED DEVICES ARE SEGREGATED, NOT FOR USE. 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 25217723 ↗
• MalfunctionApr 27, 2026Contamination; Contamination /Decontamination Problem

  THE CUSTOMER, (B)(6), CONTACTED THE DEVICE MANUFACTURER ON 09APR2026 TO REPORT DURING PACKAGING OF THE SWABBLE VIAL ADAPTER (SVA) WITH THE CUSTOMER'S DRUG PRODUCT, FOREIGN PARTICLES WERE DETECTED WITHIN THE PRIMARY PACKAGING OF THE DEVICES AND ALSO WITHIN THE SEALING AREA OF THE PRIMARY PACKAGING. THE CUSTOMER CONFIRMED THAT THE AFFECTED DEVICES ARE SEGREGATED, NOT FOR USE. 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 24999055 ↗
• MalfunctionApr 15, 2026Contamination; Contamination /Decontamination Problem

  THE CUSTOMER, DOMPE FARMACEUTICI SPA, CONTACTED THE DEVICE MANUFACTURER ON 19MAR2026 TO REPORT DURING PACKAGING OF THE SWABABLE VIAL ADAPTER (SVA) WITH THE CUSTOMER'S DRUG PRODUCT, FOREIGN PARTICLES WERE DETECTED WITHIN THE PRIMARY PACKAGING OF THE DEVICES AND ALSO WITHIN THE SEALING AREA OF THE PRIMARY PACKAGING. THE CUSTOMER CONFIRMED THAT THE AFFECTED DEVICES ARE SEGREGATED, NOT FOR USE. 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 24885765 ↗
• MalfunctionApr 2, 2026Contamination; Contamination /Decontamination Problem

  THE CUSTOMER, DOMPE FARMACEUTICI SPA, CONTACTED THE DEVICE MANUFACTURER ON 09MAR2026 TO REPORT DURING PACKAGING OF THE SWABABLE VIAL ADAPTER (SVA) WITH THE CUSTOMER'S DRUG PRODUCT, FOREIGN PARTICLES WERE DETECTED WITHIN THE PRIMARY PACKAGING OF THE DEVICES AND ALSO WITHIN THE SEALING AREA OF THE PRIMARY PACKAGING. THE CUSTOMER CONFIRMED THAT THE AFFECTED DEVICES ARE SEGREGATED, NOT FOR USE. 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 24766066 ↗
• MalfunctionMar 24, 2026Contamination; Contamination /Decontamination Problem

  THE CUSTOMER, (B)(6), CONTACTED THE DEVICE MANUFACTURER ON 24-FEB-2026 TO REPORT DURING PACKAGING OF THE SWABABLE VIAL ADAPTER (SVA) WITH THE CUSTOMER'S DRUG PRODUCT, FOREIGN PARTICLES WERE DETECTED WITHIN THE PRIMARY PACKAGING OF THE DEVICES AND ALSO WITHIN THE SEALING AREA OF THE PRIMARY PACKAGING. 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 24680855 ↗
• MalfunctionFeb 25, 2026Contamination; Contamination /Decontamination Problem

  THE CUSTOMER, (B)(6), CONTACTED THE DEVICE MANUFACTURER ON 03-FEB-2026 TO REPORT DURING PACKAGING OF THE SWABABLE VIAL ADAPTER (SVA) WITH THE CUSTOMER'S DRUG PRODUCT, FOREIGN PARTICLES WERE DETECTED WITHIN THE PRIMARY PACKAGING OF THE DEVICES AND ALSO WITHIN THE SEALING AREA OF THE PRIMARY PACKAGING. 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 24444173 ↗
• MalfunctionFeb 11, 2026Contamination; Contamination /Decontamination Problem

  THE CUSTOMER, (B)(6), CONTACTED THE DEVICE MANUFACTURER ON 16JAN2026 TO REPORT DURING PACKAGING OF THE SWABABLE VIAL ADAPTER (SVA) WITH THE CUSTOMER'S DRUG PRODUCT, FOREIGN PARTICLES WERE DETECTED WITHIN THE PRIMARY PACKAGING OF THE DEVICES AND ALSO WITHIN THE SEALING AREA OF THE PRIMARY PACKAGING. 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), AND THEREFORE THERE WAS NO HEALTH IMPACT TO THE END USER. SAMPLES HAVE BEEN REQUESTED FROM THE CUSTOMER AND WILL FORM PART OF THE INVESTIGATION ONCE RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24314829 ↗
• MalfunctionDec 23, 2025Contamination; Contamination /Decontamination Problem; Contamination; Contamination /Decontamination Problem

  THE CUSTOMER, (B)(6), CONTACTED THE DEVICE MANUFACTURER ON (B)(6) 2025 TO REPORT DURING PACKAGING OF THE SWABABLE VIAL ADAPTER (SVA) WITH THE CUSTOMER'S DRUG PRODUCT, FOREIGN PARTICLES WERE DETECTED WITHIN THE PRIMARY PACKAGING OF THE DEVICES AND ALSO WITHIN THE SEALING AREA OF THE PRIMARY PACKAGING. FOREIGN PARTICLES WERE DETECTED IN MULTIPLE DEVICES FROM LOT K717 OF THE SWABABLE VIAL ADAPTERS (SVA). THE CUSTOMER CONFIRMED THAT THE AFFECTED DEVICES ARE SEGREGATED, NOT FOR USE. AS 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 23878120 ↗
• MalfunctionDec 11, 2025Contamination; Contamination /Decontamination Problem; Contamination; Contamination /Decontamination Problem

  THE CUSTOMER, (B)(6), CONTACTED THE DEVICE MANUFACTURER ON (B)(6) 2025 TO REPORT DURING PACKAGING OF THE SWABABLE VIAL ADAPTER (SVA) WITH THE CUSTOMER'S DRUG PRODUCT, FOREIGN PARTICLES WERE DETECTED WITHIN THE PRIMARY PACKAGING OF THE DEVICES AND ALSO WITHIN THE SEALING AREA OF THE PRIMARY PACKAGING. FOREIGN PARTICLES WERE DETECTED IN MULTIPLE DEVICES FROM LOT K716 OF THE SWABABLE VIAL ADAPTERS (SVA). THE CUSTOMER CONFIRMED THAT THE AFFECTED DEVICES ARE SEGREGATED, NOT FOR USE. AS 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 23778662 ↗
• MalfunctionMar 4, 2025Contamination; Contamination of Device Ingredient or Reagent; Contamination; Contamination of Device Ingredient or Reagent

  THE CUSTOMER, DOMPÉ FARMACEUTICI, CONTACTED THE DEVICE MANUFACTURER ON 04FEB2025 TO REPORT THAT DURING DISPENSING OF THE CUSTOMER'S DRUG FOR OPHTHALMIC USE, A FOREIGN BODY WAS NOTICED INSIDE A PIPETTE (DEVICE WHICH IS USED FOR THE ADMINISTRATION OF THE DRUG) AFTER RECONSTITUTION WITH THE WEST VIAL ADAPTER. NO ADVERSE EVENT HAS BEEN REPORTED AS THE DOSE RELATED TO THE REPORTED EVENT HAS NOT BEEN ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21518537 ↗