ARROW CONTINUOUS NERVE BLOCK SET

Description of Event or Problem

THE CUSTOMER ALLEGES THAT THE DRUGS RAN OUT FROM THE PATIENT ON THE OUTER WALL OF THE STIMUCATH.

Additional Manufacturer Narrative

QN#(B)(4). THE INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

(B)(4). THE CUSTOMER RETURNED ONE CATHETER PIECE FOR INVESTIGATION. THE ENTIRE CATHETER WAS NOT RETURNED. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE CATHETER WAS SEPARATED AFTER THE 13 CM MARKER BAND. THE DISTAL TIP WAS PRESENT. THE CATHETER WAS CUT AT THE PROXIMAL END AS THE COILS AND EXTRUSION WERE NOT STRETCHED AT THE POINT OF SEPARATION. THE DISTAL BALL WELD WAS PRESENT AND INTACT. THE COILS WERE SEVERELY STRETCHED AT THE DISTAL TIP AND THE SAFETY RIBBON WAS EXPOSED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE STIMUCATH WITH NO RELEVANT FINDINGS. THE INSTRUCTIONS FOR USE (IFU) WAS REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. THE IFU STATES "DO NOT ALTER THE CATHETER OR ANY OTHER KIT/SET COMPONENT DURING PLACEMENT, USE, OR REMOVAL." THE IFU DESCRIBES SUGGESTED TECHNIQUES TO MINIMIZE THE LIKELIHOOD OF CATHETER DAMAGE DURING REMOVAL AND CAUTIONS USERS ABOUT THE USE OF ALCOHOL AND ACETONE SINCE THEY CAN WEAKEN THE STRUCTURE OF THE POLYURETHANE MATERIAL. OTHER REMARKS: THE REPORTED COMPLAINT OF A CATHETER LEAK COULD NOT BE CONFIRMED BASED ON THE CONDITION OF THE SAMPLE RECEIVED. ONLY A CATHETER PIECE WAS RECEIVED. THE RETURNED CATHETER PIECE WAS NOT RECEIVED IN A FORM THAT WOULD ALLOW FOR FUNCTIONAL TESTING TO CONFIRM A LEAK. A DHR REVIEW WAS PERFORMED ON THE CATHETER WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THEREFORE, THE POTENTIAL CAUSE OF A CATHETER LEAK COULD NOT BE DETERMINED.

Description of Event or Problem

THE CUSTOMER ALLEGES THAT THE DRUGS RAN OUT FROM THE PATIENT ON THE OUTER WALL OF THE STIMUCATH.

Additional Manufacturer Narrative

THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER, THEREFORE, A LOT NUMBER WAS CHOSEN BASED ON THE SALES HISTORY OF THE CUSTOMER. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON LOT NUMBER 23F14E0748 AND THERE WERE NO RELEVANT FINDINGS. COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED BY THE CUSTOMER FOR INVESTIGATION. A DHR REVIEW WAS PERFORMED BASED ON A LOT NUMBER FROM THE SALES HISTORY OF THE CUSTOMER, AND THERE WAS NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THE POTENTIAL CAUSE OF THE CATHETER UNRAVELING COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT A SAMPLE.