BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMICATH

    MDR report key: 10656376 · Received October 9, 2020

    Report

    Report Number
    2245270-2020-00103
    Event Type
    Malfunction
    Date Received
    October 9, 2020
    Date of Event
    August 30, 2020
    Report Date
    November 19, 2020
    Manufacturer
    VYGON USA
    Product Code
    LJS
    PMA / PMN Number
    K041468
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MALFUNCTION WAS ALSO SENT TO FDA VIA MEDWATCH REPORT NUMBER MW5096525. THE COMPLAINT WAS FORWARDED TO OUR PARENT COMPANY IN GERMANY FOR THEIR EVALUATION. THE INVESTIGATION SUMMARY IS AS FOLLOWS: WE RECEIVED A CATHETER AS A SAMPLE WITH STILL ASSEMBLED STYLET. THE DISTAL 5 CM OF THE CATHETER TUBE WAS MISSING. MICROSCOPIC EXAMINATION SHOWED THAT THE DISTAL 1 MM OF THE REMAINING CATHETER TIP WAS HALVED. NO SCRATCHES OR OTHER DAMAGES COULD BE DETECTED ON THE STYLET. WE LEARNED THAT "RESISTANCE WAS MET, SO THE PICC WAS SLOWLY WITHDRAWN WHEN IT FRACTURED LEAVING 5CM REMAINING IN THE LEG." DUE TO THIS DESCRIPTION WE ASSUME THAT THE CATHETER HAD BEEN CAUGHT IN THE NEEDLE BEVEL AND GOT CUT A LITTLE. UPON FURTHER WITHDRAWAL IT SNAPS. THIS WOULD EXPLAIN THE VERY UNIQUE APPEARANCE, WHICH WE HAVE NEVER SEEN BEFORE. A REVIEW OF THE BATCH HISTORY RECORDS SHOWED NO DEVIATIONS. EACH CATHETER IS FLOW AND LEAK TESTED DURING PRODUCTION. THE TENSILE FORCE OF THE CATHETER COMPONENTS IS RANDOMLY CHECKED. INCOMING GOODS INSPECTIONS AND TWO 100% VISUAL TESTS ARE PERFORMED AFTER PRODUCT IS PACKAGED. THIS IS THE THIRD COMPLAINT FOR THE INVOLVED BATCHES 8080365 AND 8091214 AND THE SECOND REGARDING A SNAPPED CATHETER TUBE ON CODE 4G07126103 WITHIN THE LAST THREE YEARS. NO FURTHER CORRECTIVE ACTION INITIATED BY QUALITY MANAGEMENT AS THERE ARE NO INDICATIONS OF A MANUFACTURING FAULT. CORRECTIVE ACTION: BASED ON THE INVESTIGATION, THE REPORTED CONDITION WAS NOT RELATED TO MANUFACTURING FAULT. THEREFORE, NO FURTHER CORRECTIVE WILL BE INITIATED AT THIS TIME. THIS FAILURE WILL BE MONITORED FOR FUTURE ACTIONS.

    Description of Event or Problem · 0

    PRETERM BORN AT 26+ WEEKS VIA VAGINAL DELIVERY ADMITTED TO NICU FOR PRETERM, RESPIRATORY DISTRESS AND R/O SEPSIS. PICC ORDERED FOR PARENTERAL NUTRITION-DURING CATHETER INSERTION INTO THE SAPHENOUS VEIN RESISTANCE WAS MET, SO THE PICC WAS SLOWLY WITHDRAWN WHEN IT FRACTURED LEAVING 5CM REMAINING IN THE LEG. NEONATE WAS TRANSFERRED TO AN OUTSIDE (B)(6) HOSPITAL FOR A SURGICAL CONSULT FOR RETRIEVAL.

    Additional Manufacturer Narrative · 1

    THIS MALFUNCTION WAS ALSO SENT TO FDA VIA MEDWATCH REPORT NUMBER MW5096525. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING,AND WILL BE REPORTED TO FDA WITHIN THIRTY DAYS OF ITS CONCLUSION VIA FOLLOW-UP MDR.

    Description of Event or Problem · 1

    PRETERM BORN AT (B)(6) VIA VAGINAL DELIVERY ADMITTED TO NICU FOR PRETERM, RESPIRATORY DISTRESS AND R/O SEPSIS. PICC ORDERED FOR PARENTERAL NUTRITION-DURING CATHETER INSERTION INTO THE SAPHENOUS VEIN RESISTANCE WAS MET, SO THE PICC WAS SLOWLY WITHDRAWN WHEN IT FRACTURED LEAVING 5CM REMAINING IN THE LEG. NEONATE WAS TRANSFERRED TO AN OUTSIDE (B)(6) HOSPITAL FOR A SURGICAL CONSULT FOR RETRIEVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1120057 PREMICATH LONG TERM INTRAVASCULAR CATHETER LJS VYGON USA 1261.203G 20A009D

    Patients

    Seq Age Sex Outcome Treatment
    1 26 WK