Specimen Collection Swab SW0102Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810050851909), received between Feb 25, 2021 and Feb 25, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionFeb 25, 2021Break; Break

  TYPENEX MEDICAL SPECIMEN COLLECTION SWABS (PRODUCT CODE: SW0102, LOT 08032) BROKE OFF WITHIN THE PATIENT'S NOSTRIL DURING SAMPLE COLLECTION. THE SWAB BROKE AT THE DESIGNATED BREAK POINT, THAT IS THE POINT ON THE SWAB THAT IS INTENDED TO BREAK INSIDE THE VIRAL TRANSPORT TUBE IN ORDER TO LEAVE THE FLOCKED HEAD INSIDE THE TUBE AND ALLOW THE TUBE TO BE CAPPED FOR TRANSPORT. THE PATIENT RECEIVED ADDITIONAL MEDICAL ATTENTION AT A LOCAL OUTPATIENT CARE FACILITY TO REMOVE THE SWAB TIP FROM THEIR NOSTRIL. A SIMILAR ISSUE WITH A DIFFERENT PATIENT HAS ALREADY BEEN REPORTED THAT OCCURRED ON THE SAME DAY AND AT THE SAME HOSPITAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 11378456 ↗
• MalfunctionFeb 25, 2021Break; Break

  TYPENEX MEDICAL SPECIMEN COLLECTION SWABS (PRODUCT CODE: SW0102, LOT 080320) BROKE OFF WITHIN THE PATIENT'S NOSTRIL DURING SAMPLE COLLECTION. THE SWAB BROKE AT THE DESIGNATED BREAK POINT, THAT IS THE POINT ON THE SWAB THAT IS INTENDED TO BREAK INSIDE THE VIRAL TRANSPORT TUBE IN ORDER TO LEAVE THE FLOCKED HEAD INSIDE THE TUBE AND ALLOW THE TUBE TO BE CAPPED FOR TRANSPORT. THE PATIENT RECEIVED ADDITIONAL MEDICAL ATTENTION AT A LOCAL EMERGENCY DEPARTMENT TO REMOVE THE SWAB TIP FROM THEIR NOSTRIL.

  Patient problems: Foreign Body In Patient

  MAUDE report 11378450 ↗