UMBILICAL CATHETER

Additional Manufacturer Narrative

THE INCRIMINATED SAMPLE WAS RECEIVED FOR INVESTIGATION. UPON RECEIPT OF THE COMPLAINED DEVICE, DIMENSIONAL INSPECTIONS WERE PERFORMED, CONFIRMING THAT THE CATHETER MEETS ALL ESTABLISHED TECHNICAL SPECIFICATIONS. A DETAILED ANALYSIS OF THE TUBING WAS CONDUCTED USING OPTICAL IMAGING, WHICH IDENTIFIED A CRACK NEAR THE 14MM AND 15MM MARKINGS, ADJACENT TO THE FIXATION SITE. ADDITIONALLY, A LOCALIZED OVALIZATION OF THE RADIOPAQUE (ORX) LINE WAS OBSERVED, A DEFORMATION TYPICALLY ASSOCIATED WITH EXTERNAL CLAMPING OR MECHANICAL COMPRESSION. TO VALIDATE THE IMPACT OF THIS DEFECT, A LEAK TEST WAS PERFORMED USING A CONTRAST FLUID, CONFIRMING COMPROMISED INTEGRITY AT THE IDENTIFIED LOCATION. DURING MANUFACTURING, ALL UMBILICAL CATHETERS UNDERGO 100% LEAK TESTING TO ENSURE INTEGRITY. REVIEW OF THE DOCUMENTATION FOR THE BATCH INVOLVED DID NOT REVEAL ANY ANOMALIES OR NON-CONFORMITIES. CONSIDERING THAT THE CATHETER REMAINED IN SITU FOR 5 DAYS, IT IS CONCLUDED THAT THE DAMAGE IS NOT A MANUFACTURING DEFECT. IF THE CRACK HAD BEEN PRESENT AT THE TIME OF INITIAL USE, THE RUPTURE AND RESULTING LEAKAGE WOULD HAVE BEEN DETECTED IMMEDIATELY UPON INSERTION OR PRESSURIZATION. THEREFORE, THE EVIDENCE INDICATES THAT THE DAMAGE OCCURRED DUE TO EXTERNAL FACTORS DURING CLINICAL USE OR HANDLING. ANALYSIS OF VYGON FRANCE'S HISTORICAL DATA SHOWS THAT NO SIMILAR COMPLAINTS HAVE BEEN RECORDED FOR THIS BATCH. CORRECTIVE ACTION: BASED ON VYGON FRANCE'S INVESTIGATION, THE FINDINGS INDICATE THAT THE DAMAGE RESULTED FROM EXTERNAL FACTORS DURING CLINICAL USE OR HANDLING, RATHER THAN FROM MANUFACTURING. THEREFORE, NO FURTHER CORRECTION WILL BE INITIATED AT THIS TIME.

Description of Event or Problem

SMALL BREAK/TEAR NOTED ON THE UMBILICAL ARTERIAL LINE. UMBILICAL ARTERIAL CATHETER BEGAN SQUIRTING BLOOD FROM THE LINE. THE LINE ITSELF WAS STILL SECURED AT THE EXPECTED LOCATION (AT 11CM) THE DEFECT WAS NOTED BETWEEN THE 14-15CM MARK. LINE WAS REMOVED FROM PATIENT AND STORED IN PCC OFFICE FOR SUBMISSION FOR FURTHER INVESTIGATION. PATIENT HAD BLOOD TEST DONE TO SEE IF BLOOD TRANSFUSION WAS REQUIRED AND BLOOD LOSS LED TO THE NEED FOR A BLOOD TRANSUSION.

Additional Manufacturer Narrative

THE MALFUNCTIONING DEVICE WILL BE RETURNED FOR EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. UPON RECEIPT, IT WILL BE INVESTIGATED. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING AND WILL BE REPORTED TO THE FDA WITHIN THIRTY DAYS OF ITS CONCLUSION VIA A FOLLOW-UP MDR

Description of Event or Problem

SMALL BREAK/TEAR NOTED ON THE UMBILICAL ARTERIAL LINE. UMBILICAL ARTERIAL CATHETER BEGAN SQUIRTING BLOOD FROM THE LINE. THE LINE ITSELF WAS STILL SECURED AT THE EXPECTED LOCATION (AT 11CM) THE DEFECT WAS NOTED BETWEEN THE 14-15CM MARK. LINE WAS REMOVED FROM PATIENT AND STORED IN PCC OFFICE FOR SUBMISSION FOR FURTHER INVESTIGATION. PATIENT HAD BLOOD TEST DONE TO SEE IF BLOOD TRANSFUSION WAS REQUIRED AND BLOOD LOSS LED TO THE NEED FOR A BLOOD TRANSFUSION.