MalfunctionKXF
INTL TOC PLS BCRB-INDIV 800
Received May 21, 2026 · Event occurred Mar 23, 2026
Report 0001419181-2026-00011 · MDR key 25244548
Device
Generic name
Oral Swab
Manufacturer
Sage Products LlcModel number
6075-XCatalog number
6075-X
Lot number
101938
Product problems
- Material Separation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H11: ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem
REPORT RECEIVED OF A FOAM DISENGAGEMENT. REPORTEDLY, WHEN STAFF OPENED THE ORAL SWAB WRAPPER (6075-X ORAL SWAB INDIVIDUALLY WRAPPED), THE FOAM HEAD DISENGAGED FROM THE DEVICE. THE DEVICE WAS DISCARDED AND THERE WAS NO IMPACT TO THE PATIENT. NO ADVERSE CONSEQUENCES WERE REPORTED. LOT INFORMATION WAS PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED AND NO PRODUCT WAS RETURNED.