BBL CULTURESWAB PLUS AMIES GEL WITHOUT CHARCO
Received Mar 28, 2007 · Event occurred Mar 2, 2007
Report 1119779-2007-00005 · MDR key 921761
Device
Product problems
- Component Missing
- Device Or Device Fragments Location Unknown
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
A CUSTOMER CALLED TO REPORT THAT WHILE CULTURING A PATIENT'S INCISION IN THE OPERATING ROOM (OR), THE OR NOTICED THAT ONE OF THE RAYON TIPS (THIS SWAB HAS TWO TIPS) WAS MISSING WHEN THEY WERE REPLACING THE SWAB BACK INTO THE TRANSPORT TUBE. THE SURGEONS CONDUCTED A THOROUGH SEARCH OF THE PATIENT'S INCISION AND FAILED TO FIND THE RAYON TOP AND THEY DO NOT BELIEVE THE TIP WAS LEFT IN THE INCISION. THE TIP WAS NEVER LOCATED.
Additional Manufacturer Narrative
RECORDS FOR THIS LOT OF MATERIAL WERE EXAMINED AND SHOWED NO ANOMALIES DURING MANUFACTURER OF THIS PRODUCT. A 100% VISUAL INSPECTION WAS CONDUCTED PRIOR TO BULK PACKAGING. RETENTION SAMPLES OF THIS LOT WERE VISUALLY EXAMINED FOR MISSING TIPS. SAMPLES OF THIS LOT WERE ALSO RETESTED USING A WETABILITY AND MANUAL PULL TEST TO ASSURE NO DETACHMENT OF THE SWABS FROM THE SHAFT. ALL RESULTS WERE ACCEPTABLE. BASED ON PRODUCT TRENDING AND INVESTIGATION RESULTS, THIS APPEARS TO BE AN ISOLATED INCIDENT.