MADGIC LARYNGO-TRACHEAL MUCOSAL ATOMIZAT

Description of Event or Problem

IT WAS REPORTED VIA THE MEDWATCH FORM THAT: "THE ATOMIZATION DEVICE IS DESIGNED TO BE LUER-LOCKED TO A SYRINGE TO ALLOW FOR ADMINISTRATION OF TOPICAL LOCAL ANESTHETIC. IT WAS UNRECOGNIZED THAT THE SYRINGE BECAME DISCONNECTED FROM THE ATTACHED CATHETER." THE REPORTED DEFECT WAS DETECTED DURING USE. THERE WAS NO PATIENT HARM/INJURY/CONSEQUENCE REPORTED.

Additional Manufacturer Narrative

(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. A VERIFICATION OF FAILURE MODE REPORTED IN THE CURRENT MANUFACTURING PROCESS WAS CONDUCTED AS FOLLOWS: PART NUMBER REPORTED IS NOT BEING MANUFACTURED CURRENTLY, HOWEVER, ANOTHER PART NUMBER FROM THE SAME FAMILY WAS USE FOR THE "VERIFICATION OF FAILURE MODE REPORTED IN THE CURRENT MANUFACTURING PROCESS" AND WAS CONDUCTED AS FOLLOWS: 315 SAMPLES WERE TAKEN FROM THE CURRENT PRODUCTION P/N MAD510 MADOMIZER DISPOSABLE TIP, LOT # 73E2200782, THE SAMPLES WERE VISUALLY INSPECTED, AND ISSUE REPORTED AS " DETACHED PARTS - OTHER" WAS NOT OBSERVED IN THE CURRENT MANUFACTURING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.