UMBILICAL CATHETER

Additional Manufacturer Narrative

WE RECEIVED THE INVOLVED UMBILICAL CATHETER. THE INVESTIGATION CONFIRMS THAT THE CATHETER IS BROKEN AT MARK 6. MICROSCOPIC EXAMINATION OF BOTH FRACTURED CATHETER'S SECTION, AN EVEN AND UNEVEN SURFACE WAS IDENTIFIED. FURTHERMORE, THERE ARE 2 MARKS ON THE TUBE SIMILAR TO CUT NEAR THE MARK 6 CM. THIS IS CHARACTERISTIC OF A DAMAGE OF THE TUBE BY A SHARP OBJECT AND THEN BY A TENSILE STRENGTH APPLIED ON THIS DAMAGED TUBE WHICH LED TO THE RUPTURE. MOREOVER, NO SIGN OF OBVIOUS MANUFACTURING MATERIAL WEAKNESS, WAS IDENTIFIED DURING CATHETER EXAMINATION. THIS CATHETER'S TUBE DAMAGE IS TRACED TO THE USAGE. FROM THE DESCRIPTION OF THE INCIDENT, THE CATHETER WAS FUNCTIONING CORRECTLY FOR 4 DAYS. WE DO NOT KNOW HOW THE CATHETER WAS HANDLED IN THE INCUBATOR, HOW THE DRESSING CHANGE WAS DONE ETC.... THE BATCH RECORD REVIEW OF THE 3 POSSIBLE BATCHES SHOWS THAT ALL PRODUCTS ARE IN COMPLIANCE WITH THE SPECIFICATION AND ISO 10555-1 NORM. THERE IS NO NONCONFORMITY OR DEVIATION FOUND DURING THE MANUFACTURING PROCESS.THE TENSILE STRENGTH MEASURED VALUES ARE ALL ABOVE THE MINIMUM VALUE OF ISO NORM, > 10N. THESE 3 POSSIBLE BATCHES 060422PB,110422PB, AND 230322PB WERE SOLD BETWEEN MAY AND JULY 2022 AND (B)(4) UNITS IS THE TOTAL NUMBER OF UNITS FOR THESE 3 BATCHES TOGETHER. FURTHERMORE, THE HISTORICAL DATA ANALYSIS SHOWS THAT THIS IS THE FIRST INCIDENT REPORTED FOR THESE 3 POSSIBLE BATCHES. THE ROOT CAUSE OF THIS INCIDENT WAS NOT DUE TO A DEFECT IN THE QUALITY OF THE CATHETER BUT WAS TRACED TO THE USER. THE IS A WARNING IN THE PRODUCT IFU: "DO NOT APPLY SHARP OR ROUGH-EDGED INSTRUMENTS DIRECTLY TO THE CATHETER: EVEN A MINOR CUT COULD TEAR IT OR BREAK IT. DO NOT DELIBERATELY CUT THE CATHETER.".

Description of Event or Problem

PRETERM OF 30 WEEKS IN ITS 4TH DAY OF LIFE, WEIGHT 1266GR., WITH UMBILICAL VENOUS CATHETER FIXED IN 7, WHICH MIGRATES BEING ALMOST OUTSIDE, SO IT IS REMOVED AND IT IS IDENTIFIED AS COMING OUT OF MARK 6. WHEN TAKING X-RAYS ABDOMEN IS OBSERVED PIECE OF CATHETER IN HEPATIC CIRCULATION, WITH PEDIATRIC SURGERY, UMBILICAL VEIN IS EXPLORED WITHOUT REACHING THE CATHETER, X-RAYS IS REPEATED OBSERVING MIGRATION OF THE CATHETER TO HEPATIC. THE PATIENT REQUIRED A SURGICAL INTERVENTION TO REMOVE PART OF THE CIRCULATING DEVICE IN THE UMBILICAL VEIN.

Description of Event or Problem

PRETERM OF 30 WEEKS IN ITS 4TH DAY OF LIFE, WEIGHT 1266GR., WITH UMBILICAL VENOUS CATHETER FIXED IN 7, WHICH MIGRATES BEING ALMOST OUTSIDE, SO IT IS REMOVED AND IT IS IDENTIFIED AS COMING OUT OF MARK 6. WHEN TAKING X-RAYS ABDOMEN IS OBSERVED PIECE OF CATHETER IN HEPATIC CIRCULATION, WITH PEDIATRIC SURGERY, UMBILICAL VEIN IS EXPLORED WITHOUT REACHING THE CATHETER, X-RAYS IS REPEATED OBSERVING MIGRATION OF THE CATHETER TO HEPATIC. THE PATIENT REQUIRED A SURGICAL INTERVENTION TO REMOVE PART OF THE CIRCULATING DEVICE IN THE UMBILICAL VEIN.

Additional Manufacturer Narrative

WE HAVE QUESTIONED OUR VYGON LOCAL SUBSIDIARY IN COLOMBIA IN ORDER TO RECEIVE ADDITIONAL INFORMATION ON THE CONDITION OF USE. PICTURES HAVE BEEN FORWARDED AND WE CAN CONFIRM THAT THE CATHETER IS BROKEN AT MARK 6. THE VISIBILITY IS NOT CLEAR ENOUGH TO CONFIRM THAT THE FRACTURED TUBE SECTION IS EVEN. THIS UMBILICAL CATHETER SEEMS TO HAVE BEEN IN USE FOR 4 DAYS AND IT WAS FUNCTIONING CORRECTLY UNTIL ITS FRACTURE. THE REVIEW OF THE POSSIBLE BATCHES DOES NOT SHOW ANY NON-CONFORMITY. THE PRODUCTS ARE IN CONFORMITY WITH THE SPECIFICATIONS. THE DEVICES ARE COMPLIANT WITH NORM ISO 10555-1. THE TENSILE STRENGTH MEASURED VALUES ARE ALL ABOVE THE MINIMUM VALUE OF ISO NORM, > 10N. FROM OUR HISTORICAL ANALYSIS OF COMPLAINTS, THIS IS THE FIRST COMPLAINT/INCIDENT ON THESE 3 POSSIBLE BATCHES. THESE 3 POSSIBLE BATCHES 060422PB,110422PB, AND 230322PB WERE SOLD BETWEEN MAY AND JULY 2022 AND (B)(4) UNITS IS THE TOTAL NUMBER OF UNITS FOR THESE 3 BATCHES TOGETHER. THE MOST LIKELY CAUSE OF THAT FRACTURE SEEMS TO BE TRACED TO ITS USAGE. WE ARE WAITING FOR THE INVOLVED SAMPLE AND FOR THE ADDITIONAL INFORMATION FOR INVESTIGATION.