COBAS PCR MEDIA DUAL SWAB SAMPLE KIT

Additional Manufacturer Narrative

THROUGH THE COURSE OF THE INVESTIGATION, WHICH INCLUDED A REVIEW OF QC RELEASE RECORDS AND VISUAL INSPECTION OF RETAIN MATERIALS, NO PRODUCT PROBLEM WAS FOUND. THE COBAS PCR MEDIA DUAL SWAB KIT INSTRUCTIONS FOR USE PROVIDE ADEQUATE INSTRUCTIONS FOR THE PROPER SAMPLE COLLECTION. (B)(4).

Description of Event or Problem

A (B)(6) CUSTOMER REPORTED THAT UPON TAKING A COVID SWAB, WITH THE COBAS PCR MEDIA DUAL SWAB KIT, THE SWAB BROKE. A NURSE AT THE SITE DECIDED TO TAKE A THROAT SWAB FROM THE PATIENT'S TRACHEOSTOMY SITE. UPON INSERTING THE SWAB INTO THE TRACHEOSTOMY, IT BROKE WITH THE COTTON BUDDED END FALLING FURTHER INTO THE TRACHEOSTOMY SITE, BEING LOST TO SIGHT. THE NURSE REMOVED THE INNER TRACHEOSTOMY TUBE TO ATTEMPT TO LOCATE THE SWAB BUT WAS UNABLE TO VISUALIZE IT. THE SWAB WAS REMOVED FROM L MAIN BRONCHUS THROUGH BRONCHOSCOPE UNDER PROPOFOL SEDATION BY A RESPIRATORY CONSULTANT. THE SAMPLE WAS TAKEN FOR COVID TESTING, BUT NO FURTHER DETAILS ON WHICH TEST IT WAS COLLECTED FOR WAS PROVIDED. THE INSTRUCTIONS FOR USE FOR THE COBAS PCR MEDIA DUAL SWAB KIT DO NOT INSTRUCT THE USER TO COLLECT SAMPLES FROM TRACHEOSTOMY SITES. IT DOES, HOWEVER, PROVIDE INSTRUCTION ON THE PROPER COLLECTION OF OROPHARANYGEAL SAMPLES.