UMBILICAL CATHETER

Additional Manufacturer Narrative

WE RECEIVED THE INVOLVED UMBILICAL CATHETER CODE 270.03, BATCH 020525PB. WE CONTACTED THE REPORTER TO OBTAIN ADDITIONAL INFORMATION REGARDING ITS DURATION OF PLACEMENT, FIXATION, CONDITIONS OF USE, AND THE PATIENT. THEY WERE UNABLE TO PROVIDE ANY FURTHER DETAILS. THE CATHETER IS IN FOUR SEPARATE FRAGMENTS: FRAGMENT 1: MEASURES APPROXIMATELY 55 MM. IT INCLUDES MARKINGS 4 TO 6, BUT THE DISTAL END OF THE CATHETER IS MISSING. THE DISTANCE BETWEEN THE END OF THE RECEIVED FRAGMENT AND MARKING 5 IS 38 MM, WHEREAS THE SPECIFICATION BETWEEN THE DISTAL END OF THE CATHETER AND THE 5 CM MARKING IS 50 MM± 1 MM. THE DISTAL END OF THIS SECTION SHOWS A CLEAN, BEVELED CUT. THE DISTAL END OF AN UMBILICAL CATHETER SHOULD BE ROUNDED. THIS ROUNDING OPERATION, PERFORMED DURING PRODUCTION, IS 100% VERIFIED. IT IS THEREFORE MISSING. WE CAN OBSERVE AN OVAL PERFORATION BETWEEN THE DISTAL END AND MARKING 4, MEASURING 1.27 MM BY 0.54 MM. FRAGMENT 2: MEASURES APPROXIMATELY 30 MM, WITH MARKS AND SMALL NOTCHES ALL AROUND, AND MARKING NUMBER 7 IS MISSING. IT DOES NOT ALIGN WITH FRAGMENT 1, LIKELY DUE TO THE ABSENCE OF MARKING NUMBER 7. FRAGMENT 3: MEASURES APPROXIMATELY 0.85 MM AND ALSO SHOWS MARKS AND SMALL NOTCHES. ADHESIVE TRACES ARE VISIBLE. IT FITS WITH FRAGMENTS 2 AND 4. FRAGMENT 4: MEASURES APPROXIMATELY 260 MM. PART OF THE CUT SURFACE SHOWS A CLEAN CUT, WHILE ANOTHER PART SHOWS SIGNS OF FRAYING. THIS UMBILICAL CATHETER HAS BEEN SEVERELY DAMAGED, WITH CUTS AND NUMEROUS CUT MARKS. THE BATCH RECORD REVIEW SHOWS THAT THESE UMBILICAL CATHETERS COMPLY WITH SPECIFICATIONS. ALL INSPECTIONS PERFORMED WERE COMPLIANT, INCLUDING UNIT CHECKS CARRIED OUT ON EACH CATHETER DURING THE MANUFACTURING PROCESS, SUCH AS VERIFICATION OF THE ROUNDING OF THE CATHETER TIP AND CATHETER MARKINGS. ALL OUR UMBILICAL CATHETERS ARE ALSO SUBJECT TO UNIT CHECKS FOR TOTAL LENGTH COMPLIANCE, AS WELL AS 100% CHECKS FOR NON OBSTRUCTION AND LEAK TIGHTNESS. THEIR TENSILE STRENGTH IS ALSO COMPLIANT. THE INSTRUCTION FOR USE OF THESE UMBILICAL CATHETERS DESCRIBES THE INSERTION TECHNIQUE WITH PRECAUTIONS, POSITIONING CHECKS, AND PRECAUTIONS FOR CATHETER REMOVAL: "REMOVAL: THE CATHETER INSERTION SITE SHOULD BE CLEANED CAREFULLY PRIOR TO CATHETER WITHDRAWAL. THE CATHETER IS REMOVED BY GENTLE SUSTAINED TRACTION CLOSE TO THE EXIT SITE (2-3 CM). DO NOT OVER STRETCH THE CATHETER." WE ALSO RECOMMEND: "DO NOT CRIMP OR BEND THE CATHETER FOR OCCLUDING IT, EVEN TEMPORARILY. DO NOT ADD CLAMP ON SINGLE-LUMEN CATHETERS. THIS ADDITIONAL STRESS ON THE CATHETER CAN LEAD TO LEAKS OR CRACKS. DO NOT APPLY SHARP OR ROUGH-EDGED INSTRUMENTS DIRECTLY TO THE CATHETER: EVEN A MINOR CUT COULD TEAR IT OR BREAK IT." THE HISTORICAL ANALYSIS OF SIMILAR INCIDENT OVER THE PAST THREE YEARS FOR THIS REFERENCE SHOWS THAT WE REGISTERED THREE CATHETER RUPTURES DURING REMOVAL PROCEDURES. WE RECEIVED TWO INVOLVED CATHETERS; ANALYSIS REVEALED A CUT IN THE TUBE AS THE ROOT CAUSE OF THE RUPTURE. NO CASE WAS LINKED TO THE QUALITY OF THE DEVICE. BASED ON ALL THESE DATA, THE CATHETER BREAKAGE DURING REMOVAL IS NOT TRACED TO A DEFECT OF THE CATHETER.

Description of Event or Problem

THE SERIOUS ADVERSE EVENT OCCURRED DURING CATHETER REMOVAL. DEVICE FRACTURE OCCURED 3 TIMES DURING CATHETER'S REMOVAL. POST-PROCEDURAL CHEST X-RAY REVEALED A RETAINED CATHETER FRAGMENT. ULTRASOUND LOCALIZATION IDENTIFIED ONE FRAGMENT (APPROXIMATELY 1 MM) IMMEDIATELY ABOVE THE PULMONARY VALVE AND ANOTHER WITHIN THE INFUNDIBULUM. THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR SURGICAL REMOVAL OF THE FRAGMENTS. NO ADVERSE CLINICAL CONSEQUENCES FOR THE PATIENT WERE OBSERVED.

Additional Manufacturer Narrative

THE INVOLVED UMBILICAL CATHETER IS AVAILABLE; WE ARE WAITING FOR IT FOR THE INVESTIGATION. THE REVIEW OF THE BATCH DOES NOT SHOW ANY NON-CONFORMITY. THE PRODUCTS ARE IN CONFORMITY WITH THE SPECIFICATIONS. ALL CONTROLS ARE COMPLIANT, INCLUDING THE 100% TESTS CARRIED OUT ON EACH CATHETER DURING THE MANUFACTURING PROCESS. THESE TESTS ARE AS FOLLOWS: THE BLUNTNESS OF THE CATHETER TIP, MARKING THE CATHETERS, USEFUL LENGTH, TIGHTNESS AND NON-OBSTRUCTION. IN ADDITION, 20 UMBILICAL CATHETERS ARE TESTED BY SAMPLING TO CHECK THE TENSILE STRENGTH ACCORDING TO ACCORDING TO NF EN ISO 10555-1 SPECIFICATION >10N. ALL RESULTS ARE COMPLIANT. THE HISTORICAL DATA ANALYSIS OF COMPLAINTS ON THIS BATCH DOES NOT SHOW ANY COMPLAINT. THIS SERIOUS ADVERSE EVENT IS NOT TO BE CAUSED BY A CATHETER MALFUNCTION BUT TRACED TO ITS REMOVAL PROCEDURE. WE HAVE REQUESTED ADDITIONAL INFORMATION AND ARE AWAITING THEIR RESPONSE ALONG WITH THE INVOLVED SAMPLE FOR INVESTIGATION.

Description of Event or Problem

THE SERIOUS ADVERSE EVENT OCCURRED DURING CATHETER REMOVAL. DEVICE FRACTURE OCCURED 3 TIMES DURING CATHETER'S REMOVAL. POST-PROCEDURAL CHEST X-RAY REVEALED A RETAINED CATHETER FRAGMENT. ULTRASOUND LOCALIZATION IDENTIFIED ONE FRAGMENT (APPROXIMATELY 1 MM) IMMEDIATELY ABOVE THE PULMONARY VALVE AND ANOTHER WITHIN THE INFUNDIBULUM. THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR SURGICAL REMOVAL OF THE FRAGMENTS. NO ADVERSE CLINICAL CONSEQUENCES FOR THE PATIENT WERE OBSERVED.