THORA/PARA TRAY, 5FR, NON-VALVED

Additional Manufacturer Narrative

H11: THE LOT NUMBER WAS NOT PROVIDED; A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. PHOTOS WERE NOT PROVIDED FOR REVIEW. THE DEVICE HAS NOT BEEN RETURNED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. B3 (DATE OF EVENT) THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER (AWARENESS DATE) WAS ENTERED INTO THE DATE OF EVENT FIELD. D4 (EXPIRATION DATE IS UNKNOWN), H4 (DEVICE MANUFACTURING DATE IS UNKNOWN). SECTION A THROUGH F ¿ THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

IT WAS REPORTED THAT MULTIPLE THORA/PARA NEEDLES WERE UNABLE TO PIERCE THE SKIN WITHOUT A PRE-CUT NICK. FOLLOWING INITIAL SKIN ACCESS, THE NEEDLES ADVANCED ROUGHLY THROUGH THE TISSUE, DESCRIBED AS SIMILAR TO A CATHETER ACCORDION EFFECT OR THE CANNULA EDGE CATCHING ON TISSUE RATHER THAN ADVANCING SMOOTHLY. THERE IS NO DEVICE TO RETURN FOR EVALUATION.