BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GBX CATHETER, IRRIGATION

    MDR report key: 7337382 · Received March 14, 2018

    Report

    Report Number
    1820334-2018-00653
    Event Type
    Injury
    Date Received
    March 14, 2018
    Report Date
    May 23, 2018
    Manufacturer
    COOK INC
    Product Code
    GBX
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: RANGES OVER 6 MONTHS ESTIMATED TO BE (B)(6) 2017 THRU (B)(6) 2018. (B)(4). PMA/ 510K -- EXEMPT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: A REVIEW OF THE QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. PER THE CUSTOMER: THE TWO GPN'S CITED FOR THIS FAILURE ARE G55723 AND G03974, AS THE CUSTOMER COULD NOT IDENTIFY WHICH GPN OF THESE TWO WAS RESPONSIBLE. THESE ARE RPN'S C-PPD-850-IMH AND C-PPD-850 RESPECTIVELY. THE DOCUMENTATION REVIEW COVERED BOTH POSSIBLE RPNS. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT LOT SEARCH COULD NOT BE CONDUCTED. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED OVER THE PAST SIX MONTHS APPROXIMATELY TWENTY "PIGTAIL" CATHETERS (8.5 FR PLEURAL /PNEUMOPERICARDIAL DRAINAGE CATHETERS) AMONGST FOUR DIFFERENT DOCTORS WERE DIFFICULT TO INSERT AND HAVE KINKED OR LEAKED WITHIN 24/48 HOURS AFTER IMPLANTATION. THIS MANUFACTURER REPORT NUMBER ADDRESSES UNSPECIFIED PRODUCT CODES AND UNSPECIFIED QUANTITIES OF THE LEAKING CATHETERS FOR WHICH ANOTHER CATHETER HAD TO BE PLACED. ADDITIONAL INFORMATION RELATED TO THE SPECIFIC DETAILS HAS BEEN REQUESTED BUT HAS NOT BEEN PROVIDED AT THIS TIME. THE DEVICE IS REPORTEDLY UNAVAILABLE FOR RETURN AND INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182607 GBX CATHETER, IRRIGATION GBX COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention