MOLECULAR SWAB COLLECTION KIT
Received Aug 12, 2024 · Event occurred Aug 5, 2024
Report MW5158365 · MDR key 19975757
Device
Generic name
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Manufacturer
Bd / Geneohm Sciences Canada, Ulc.Model number
443925Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
BD MOLECULAR SWAB COLLECTION KIT REF 443925-- THE SWAB WAS NOT BROKEN OFF AT THE APPROPRIATE MARK. A SWAB THAT IS TOO LONG CAN CAUSE LEAKAGE OF SAMPLE, CROSS-CONTAMINATION OR AN INSTRUMENT FAILURE. TESTING WILL STILL BE PERFORMED. THIS IS AN ONGOING ISSUE SINCE LATE 2023. REVIEW OF THESE INCIDENTS INDICATE THAT THERE IS WIDESPREAD CONFUSION WHERE TO BREAK THE SWAB. THERE IS A SOLID BLACK LINE HOWEVER THE SCORED BREAK POINT IN LOWER ON THE SWAB. RECOMMENDATION INCLUDES HAVING THE BLACK LINE REMOVED OR PLACING ON THE SCORED AREA OF THE SWAB.