COBAS® PCR MEDIA UNI SWAB SAMPLE KIT

Additional Manufacturer Narrative

THROUGH THE REPORTED CASE, IT WAS NOTED THAT THE COBAS PCR MEDIA UNI SWAB WAS NOT BROKEN PRIOR TO USE AND IT WAS LIKELY BROKEN AT THE SCORE-LINE BY THE PATIENT DURING SAMPLE COLLECTION DUE TO THEIR GAG REFLEX. INSTRUCTIONS EXIST IN THE COBAS PCR MEDIA UNI SWAB KIT INSTRUCTIONS FOR USE REGARDING PROPER SAMPLE COLLECTION. FACILITY NAME WAS TRUNCATED DUE TO CHARACTER LIMITATIONS. THE NAME OF THE FACILITY IS: (B)(4). (B)(4).

Description of Event or Problem

A CUSTOMER IN (B)(6) REPORTED A PATIENT SWALLOWED THE SHAFT OF THE COBAS PCR MEDIA UNI SWAB DURING COLLECTION OF A SPECIMEN FROM THE BILATERAL POSTERIOR PHARYNX. AS A CONSEQUENCE, THE PATIENT WAS BROUGHT INTO THE INTENSIVE CARE UNIT AND UNDERWENT TWO PROCEDURES (BRONCHOSCOPY AND ENDOSCOPY) TO LOCATE THE SWALLOWED SWAB SHAFT. THE SWAB SHAFT WAS LOCATED IN THE PATIENT'S UPPER THIRD OF THE ESOPHAGUS, AND WAS SUCCESSFULLY REMOVED. THE PATIENT IS NOW REPORTED AS DOING WELL.