BD BBL¿ CULTURESWAB¿ PLUS AMIES GEL WITHOUT CHARCOAL, DOUBLE SWAB

Description of Event or Problem

IT WAS REPORTED THAT BD BBL¿ CULTURESWAB¿ PLUS AMIES GEL WITHOUT CHARCOAL, DOUBLE SWAB WAS FOUND TO HAVE BIOLOGICALS ARTIFACTS IN THE MEDIA. THIS EVENT OCCURRED 2 TIMES. NO CONFIRMATORY TESTING WAS DONE. NO RESULTS WERE REPORTED TO CLINICIAN OR PATIENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTING WHAT APPEARS TO BE ARTIFACTS IN THE GEL OF THE CULTURESWAB CATALOG# 220117, LOT# 211031600. THE CUSTOMER STATES THEY LOOK LIKE YEAST ON THE GRAM STAIN BUT ARE SMALLER. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER CONFIRMED THAT THE CULTURES CAME BACK NEGATIVE FOR YEAST ON THE PATIENT SAMPLES. AN UN-INOCULATED SWAB WAS GRAM-STAINED AND CULTURED AND IT ALSO HAD THE SMALL YEAST-LIKE APPEARING ARTIFACTS WHICH LIKEWISE DID NOT GROW ON THE CULTURE."

Additional Manufacturer Narrative

A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT BD BBL¿ CULTURESWAB¿ PLUS AMIES GEL WITHOUT CHARCOAL, DOUBLE SWAB WAS FOUND TO HAVE BIOLOGICALS ARTIFACTS IN THE MEDIA. THIS EVENT OCCURRED 2 TIMES. NO CONFIRMATORY TESTING WAS DONE. NO RESULTS WERE REPORTED TO CLINICIAN OR PATIENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTING WHAT APPEARS TO BE ARTIFACTS IN THE GEL OF THE CULTURESWAB CATALOG# 220117, LOT# 211031600. THE CUSTOMER STATES THEY LOOK LIKE YEAST ON THE GRAM STAIN BUT ARE SMALLER. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER CONFIRMED THAT THE CULTURES CAME BACK NEGATIVE FOR YEAST ON THE PATIENT SAMPLES. AN UN-INOCULATED SWAB WAS GRAM-STAINED AND CULTURED AND IT ALSO HAD THE SMALL YEAST-LIKE APPEARING ARTIFACTS WHICH LIKEWISE DID NOT GROW ON THE CULTURE. "

Additional Manufacturer Narrative

H.6: DEVICE EVALUATION: THE CUSTOMER COMPLAINT OF ARTIFACTS IN THE GEL OF CAT. 220117, LOT 211031600 WAS NOT CONFIRMED. THE RETURNED SAMPLES FROM THE CUSTOMER WERE REVIEWED AND NO ARTIFACTS WERE OBSERVED. AN INVESTIGATION OF THE RETAIN SAMPLES AND THE DEVICE HISTORY RECORD DID NOT SHOW ANY DEFECTS. A REVIEW OF PAST COMPLAINTS FOR THIS PRODUCT DOES NOT INDICATE A TREND FOR THIS ISSUE. NO FURTHER ACTION WILL BE TAKEN AS THIS IS AN ISOLATED INCIDENT. BD QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR TRENDING.