UMBILICAL CATHETER

Additional Manufacturer Narrative

THIS MALFUNCTION WAS SENT TO FDA VIA REPORT NUMBER (B)(4). ALTHOUGH THE MALFUNCTIONING DEVICE WILL NOT BE RETURNED TO VYGON, THE DETAILS OF THE MALFUNCTION WILL BE EVALUATED AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THE INVESTIGATION ARE STILL PENDING AND WILL BE COMMUNICATED TO THE FDA.

Description of Event or Problem

NNP WAS PLACING AN UMBILICAL VENOUS CATHETER. THE NUMBERS ON THE CATHETER WORE OFF AS SOON AS SHE TOUCHED THEM. IT WAS DIFFICULT FOR HER TO KNOW HOW DEEP THE LINE WAS. WAS NOT REMOVED FROM SERVICE AS CATHETER WAS ALREADY INSERTED INTO UMBILICUS AND CATHETER WAS FUNCTIONAL. WAS MORE BENEFICIAL TO BABY TO LEAVE IN RATHER THAN REPLACE WITH A NEW CATHETER. DEPTH WAS ESTIMATED. INITIALLY HAD ISSUE FLUSHING AND DRAWING BACK ON CATHETER. LINE WAS PULLED BACK TO LOW LYING AND THEN REMOVED WHEN PIV WAS PLACED.

Description of Event or Problem

NNP WAS PLACING AN UMBILICAL VENOUS CATHETER. THE NUMBERS ON THE CATHETER WORE OFF AS SOON AS SHE TOUCHED THEM. IT WAS DIFFICULT FOR HER TO KNOW HOW DEEP THE LINE WAS. WAS NOT REMOVED FROM SERVICE AS CATHETER WAS ALREADY INSERTED INTO UMBILICUS AND CATHETER WAS FUNCTIONAL. IT WAS MORE BENEFICIAL TO BABY TO LEAVE IN RATHER THAN REPLACE WITH A NEW CATHETER. DEPTH WAS ESTIMATED. INITIALLY HAD ISSUE FLUSHING AND DRAWING BACK ON CATHETER. LINE WAS PULLED BACK TO LOW LYING AND THEN REMOVED WHEN PIV WAS PLACED.

Additional Manufacturer Narrative

THE SAMPLE IN QUESTION WAS NOT RETURNED FOR ANALYSIS; HOWEVER, THREE UNOPENED SAMPLES FROM THE SAME LOT HAVE BEEN RECEIVED AND ANALYZED FOR MARKING ISSUES. THE SAMPLES WERE INSPECTED UPON RECEIPT AND FOUND TO BE COMPLIANT, WITH NO MARKING DEFECTS IDENTIFIED. A WIPE TEST WAS PERFORMED USING A DRY CLOTH, FOLLOWED BY A DAMP CLOTH SOAKED IN ETHANOL. NO ERASURE OF MARKINGS WAS OBSERVED ON ANY OF THE THREE SAMPLES. ADDITIONALLY, ETHANOL-SOAKED COMPRESSES WERE APPLIED TO ALL THREE SAMPLES FOR 12 HOURS, AND THE MARKINGS REMAINED COMPLIANT. THE SAMPLE WOULD HAVE AIDED THE INVESTIGATION, AS WITHOUT IT, WE CANNOT DETERMINE THE EXACT ORIGIN OF THE DEFECT. HOWEVER, THE DEFECT APPEARS TO BE RELATED TO THE CONDITIONS OF USE, PARTICULARLY THE USE OF SOLVENT. THE IFU STATES: CAUTION: BE AWARE THAT ORGANIC SOLVENTS SUCH AS ALCOHOL OR ACETONE MAY INTERACT WITH CATHETER MATERIAL AND WEAKEN IT. A REVIEW OF THE BATCH RECORD REVIEW WAS COMPLIANT, WITH NO ANOMALIES FOUND DURING PRODUCTION. THIS IS AN ISOLATED CASE, AND WE HAVE NOT RECEIVED ANY COMPLAINTS REGARDING THIS BATCH OR CODE OVER THE PAST THREE YEARS. CORRECTIVE ACTION: SINCE THE DEFECTIVE SAMPLE WAS NOT RETURNED AND NO DEFECTS WERE FOUND IN THE UNOPENED SAMPLES, THE COMPLAINT CANNOT BE CONFIRMED. THEREFORE, NO FURTHER CORRECTIVE ACTION WILL BE INITIATED AT THIS TIME.