BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXT DRAINAGE SYSTEM III WITHOUT VENT CATH

    MDR report key: 3821451 · Received May 20, 2014

    Report

    Report Number
    1226348-2014-11655
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    January 3, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK954021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP IS BEING SUBMITTED TO CORRECT MW-118518 WHICH FAILED TO MENTION THAT ADDITIONAL INFORMATION WAS RECEIVED WHICH EXPLAINS WHY THE COMPLAINT WAS CLOSED AND REOPENED. THIS COMPLAINT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    THE EDSIII DEVICE WAS RETURNED FOR EVALUATION. THE INVESTIGATION OF THE EDS III DID NOT CONFIRM THE PROBLEM REPORTED BY THE CUSTOMER. THE LOT NUMBER IS CPFC4K, PRODUCT CODE 82-1731. -THE EDS III WAS VISUALLY INSPECTED AND BIOLOGICAL DEBRIS WAS NOTED ON THE FILTER IN THE DRIP CHAMBER. THE EDS III WAS SET UP AS PER IFU. THE DRIP CHAMBER STOP COCK WAS TURNED TO THE OFF POSITION SO THAT THE PURIFIED WATER STAYED IN THE DRIP CHAMBER. THE DRIP CHAMBER WAS THEN FILLED UP TO THE 20ML MARK WITH PURIFIED WATER. THE SYSTEM STOPCOCK WAS THEN CLOSED. THE DRIP CHAMBER STOPCOCK WAS OPENED, THE PURIFIED WATER FLOWED AND EMPTIED INTO THE COLLECTION BAG, WITH NO PROBLEM THE LOT NUMBER CPFC4K IS NOT FOR PRODUCT CODE 82-1731, THE DEVICE RECEIVED IS A 82-1731. -REVIEW OF THE HISTORY DEVICE RECORDS WAS NOT POSSIBLE AS THE LOT NUMBER NOTED IN ETQ IS NOT FOR PRODUCT CODE 82-1731. THE ROOT CAUSE OF THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED, AS THE PROBLEM REPORTED COULD NOT BE DUPLICATED. NO CORRECTIVE ACTION IS NEEDED BASED ON THE RESULTS OF THE EVALUATION. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. PLEASE NOTE THAT EXPIRATION DATE AND THE DEVICE MANUFACTURE DATE IS UNKNOWN SINCE NO LOT NUMBER IS AVAILABLE BASED ON THE ABOVE EVALUATION. THIS COMPLAINT IS CONSIDERED CLOSED. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    THE EDSIII DEVICE WAS RETURNED FOR EVALUATION. THE INVESTIGATION OF THE EDS III DID NOT CONFIRM THE PROBLEM REPORTED BY THE CUSTOMER. THE LOT NUMBER IS CPFC4K, PRODUCT CODE 82-1731. -THE EDS III WAS VISUALLY INSPECTED AND BIOLOGICAL DEBRIS WAS NOTED ON THE FILTER IN THE DRIP CHAMBER. THE EDS III WAS SET UP AS PER IFU. THE DRIP CHAMBER STOP COCK WAS TURNED TO THE OFF POSITION SO THAT THE PURIFIED WATER STAYED IN THE DRIP CHAMBER. THE DRIP CHAMBER WAS THEN FILLED UP TO THE 20ML MARK WITH PURIFIED WATER. THE SYSTEM STOPCOCK WAS THEN CLOSED. THE DRIP CHAMBER STOPCOCK WAS OPENED, THE PURIFIED WATER FLOWED AND EMPTED INTO THE COLLECTION BAG, WITH NO PROBLEM. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. THE ROOT CAUSE OF THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED, AS THE PROBLEM REPORTED COULD NOT BE DUPLICATED. NO CORRECTIVE ACTION IS NEEDED BASED ON THE RESULTS OF THE EVALUATION. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF INVESTIGATION A FOLLOW UP REPORT WILL BE FILED. DEVICE IS UNDER INVESTIGATION.

    Description of Event or Problem · 1

    EMAIL TO CUSTOMER: I HAVE JUST NOTICED THAT THE LOT NUMBER FOR COMPLAINT (B)(4) IS FOR PRODUCT CODE 82-1745, AND NOT 82-1731 WILL YOU BE ABLE TO FIND ME THE CORRECT LOT NUMBER FOR PRODUCT CODE 82-1731 FOR THE DEVICE THAT I RECEIVED FOR INVESTIGATION, I WILL HAVE THIS COMPLAINT REOPENED AND UPDATE THE REPORT, PLEASE LET ME KNOW IF THIS IS POSSIBLE. RESPONSE FROM CUSTOMER: THE INFORMATION RECEIVED WAS NOT CLEAR. IT COULD BE CPFC4K OR CPFCNM. COULD ONE OF THE LOT NUMBER BE CORRECT WITH 82-1731 ? EMAIL TO CUSTOMER: NO THE CPFCNM IS FOR PRODUCT CODE 82-1735. I WILL HAVE THE COMPLAINT REOPENED AND UPDATE THE REPORT.

    Description of Event or Problem · 1

    EMAIL TO CUSTOMER: I HAVE JUST NOTICED THAT THE LOT NUMBER FOR COMPLAINT (B)(4) IS FOR PRODUCT CODE 82-1745, AND NOT 82-1731 WILL YOU BE ABLE TO FIND ME THE CORRECT LOT NUMBER FOR PRODUCT CODE 82-1731 FOR THE DEVICE THAT I RECEIVED FOR INVESTIGATION, I WILL HAVE THIS COMPLAINT REOPENED AND UPDATE THE REPORT, PLEASE LET ME KNOW IF THIS IS POSSIBLE. RESPONSE FROM CUSTOMER: THE INFORMATION RECEIVED WAS NOT CLEAR. IT COULD BE CPFC4K OR CPFCNM. COULD ONE OF THE LOT NUMBER BE CORRECT WITH 82-1731 ? EMAIL TO CUSTOMER: NO THE CPFCNM IS FOR PRODUCT CODE 82-1735. I WILL HAVE THE COMPLAINT REOPENED AND UPDATE THE REPORT.

    Description of Event or Problem · 1

    DIFFICULTY TO DRAIN THE COLLECTION BAG. NO MENINGITIS DECLARED. THE INCIDENT HAS BEEN REPORTED BY THE HOSPITAL TO (B)(4). THE DEVICE HAS BEEN RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300443 EXT DRAINAGE SYSTEM III WITHOUT VENT CATH SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention