BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERAL FEEDING ADAPTER

    MDR report key: 5270912 · Received December 7, 2015

    Report

    Report Number
    1820334-2015-00845
    Event Type
    Injury
    Date Received
    December 7, 2015
    Date of Event
    October 9, 2015
    Report Date
    November 17, 2015
    Manufacturer
    COOK INC
    Product Code
    KGZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION/EVALUATION: A CLINICAL REVIEW WAS CARRIED OUT. WHEN THE ADAPTER DOES NOT STAY ON PROPERLY, PATIENT MAY NOT RECEIVE ACCURATE FOOD/LIQUIDS AND IT¿S AN ANNOYANCE TO THE PATIENT AND THE CAREGIVER. IN THIS CASE, PATIENT WAS REPORTED TO RECEIVE IMPROPER NUTRITION AND WAS LOSING WEIGHT. BASED ON THE AVAILABLE INFORMATION IT¿S POSSIBLE THE ADAPTOR MAY NOT HAVE BEEN FUNCTIONING AS INTENDED. THIS IS NOT A LIFE THREATENING SITUATION. NO ADDITIONAL INTERVENTION WAS DONE. THE ROOT CAUSE OF THE REPORTED EVENT MAY BE ASSOCIATED WITH THE EVENTUAL MALFUNCTION OF THE DEVICE. IF THE DEVICE WILL BE RETURNED THE INVESTIGATION WILL CLARIFY THE EVENTUAL ROOT CAUSE. DURING THE COURSE OF THE INVESTIGATION, A REVIEW OF THE COMPLAINT HISTORY, QUALITY CONTROL, AND DRAWING OF THE PRODUCT WAS CONDUCTED. HOWEVER, WITHOUT VISUAL, DIMENSIONAL, OR FUNCTIONAL TESTING OF THE PRODUCT, A DEFINITIVE CAUSE OF THE FAILURE MODE WAS UNABLE TO BE DETERMINED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MANUFACTURED TO CURRENT SPECIFICATIONS. MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE NOTED. A SEARCH REVEALED THIS COMPLAINT TO BE THE ONLY REPORTED COMPLAINT ASSOCIATED TO THE COMPLAINT LOT NUMBER 6132222. WE WILL CONTINUE TO MONITOR FOR SIMILAR REPORTS.

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT IS STILL UNDER INVESTIGATION AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION/EVALUATION: DURING THE COURSE OF THE INVESTIGATION, A REVIEW OF THE COMPLAINT HISTORY, QUALITY CONTROL, AND DRAWING OF THE PRODUCT WAS CONDUCTED. HOWEVER, WITHOUT VISUAL, DIMENSIONAL, OR FUNCTIONAL TESTING OF THE PRODUCT, A DEFINITIVE CAUSE OF THE FAILURE MODE WAS UNABLE TO BE DETERMINED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MANUFACTURED TO CURRENT SPECIFICATIONS. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    INFORMATION WAS PROVIDED BY THE MOTHER OF A (B)(6) FEMALE PATIENT; WHO HAD A GASTROSTOMY TUBE PLACED ON (B)(6) 2015. SINCE THE IMPLANT DATE, THE PATIENT'S MOTHER HAS CHANGED THE RED ADAPTER AT THE END OF THE TUBE 4 TIMES. THE FIRST ADAPTOR WAS USED FOR THREE WEEKS, THE NEXT ADAPTOR LASTED TWO WEEKS AND THE MOST RECENT TWO ADAPTORS ALSO REQUIRED TO BE CHANGED. THE MOTHER FURTHER ADVISED THAT THE SPECIFIC PROBLEM IS THAT WHEN THE PATIENT IS NOT BEING FED, THE RED PLUG ON THE ADAPTOR WILL NOT STAY IN PLACE AND WHEN THE PATIENT IS BEING FED, THE CONNECTOR AT THE END OF THE FEEDING BAG CONSTANTLY COMES OUT. AS A RESULT, NOT ONLY DOES THE PATIENT HAVE FORMULA AND STOMACH CONTENTS GETTING EVERYWHERE, BUT THE MOTHER IS NOT ABLE TO GET THE PATIENT'S VOLUME INTO THE PATIENT, NOT KNOWING HOW MUCH HAS BEEN LOST AND AT THIS TIME THE PATIENT IS LOSING WEIGHT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REGARDING THE OUTCOME OF THE PATIENT.

    Description of Event or Problem · 1

    INFORMATION WAS PROVIDED BY THE MOTHER OF A (B)(6) FEMALE PATIENT; WHO HAD A GASTROSTOMY TUBE PLACED ON (B)(6) 2015. SINCE THE IMPLANT DATE, THE PATIENT'S MOTHER HAS CHANGED THE RED ADAPTER AT THE END OF THE TUBE 4 TIMES. THE FIRST ADAPTOR WAS USED FOR THREE WEEKS, THE NEXT ADAPTOR LASTED TWO WEEKS AND THE MOST RECENT TWO ADAPTORS ALSO REQUIRED TO BE CHANGED. THE MOTHER FURTHER ADVISED THAT THE SPECIFIC PROBLEM IS THAT WHEN THE PATIENT IS NOT BEING FED, THE RED PLUG ON THE ADAPTOR WILL NOT STAY IN PLACE AND WHEN THE PATIENT IS BEING FED, THE CONNECTOR AT THE END OF THE FEEDING BAG CONSTANTLY COMES OUT. AS A RESULT, NOT ONLY DOES THE PATIENT HAVE FORMULA AND STOMACH CONTENTS GETTING EVERYWHERE, BUT THE MOTHER IS NOT ABLE TO GET THE PATIENT'S VOLUME INTO THE PATIENT, NOT KNOWING HOW MUCH HAS BEEN LOST AND AT THIS TIME THE PATIENT IS LOSING WEIGHT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REGARDING THE OUTCOME OF THE PATIENT.

    Description of Event or Problem · 1

    INFORMATION WAS PROVIDED BY THE MOTHER OF A (B)(6) FEMALE PATIENT; WHO HAD A GASTROSTOMY TUBE PLACED ON (B)(6) 2015. SINCE THE IMPLANT DATE, THE PATIENT'S MOTHER HAS CHANGED THE RED ADAPTER AT THE END OF THE TUBE 4 TIMES. THE FIRST ADAPTOR WAS USED FOR THREE WEEKS, THE NEXT ADAPTOR LASTED TWO WEEKS AND THE MOST RECENT TWO ADAPTORS ALSO REQUIRED TO BE CHANGED. THE MOTHER FURTHER ADVISED THAT THE SPECIFIC PROBLEM IS THAT WHEN THE PATIENT IS NOT BEING FED, THE RED PLUG ON THE ADAPTOR WILL NOT STAY IN PLACE AND WHEN THE PATIENT IS BEING FED, THE CONNECTOR AT THE END OF THE FEEDING BAG CONSTANTLY COMES OUT. AS A RESULT, NOT ONLY DOES THE PATIENT HAVE FORMULA AND STOMACH CONTENTS GETTING EVERYWHERE, BUT THE MOTHER IS NOT ABLE TO GET THE PATIENT'S VOLUME INTO THE PATIENT, NOT KNOWING HOW MUCH HAS BEEN LOST AND AT THIS TIME THE PATIENT IS LOSING WEIGHT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REGARDING THE OUTCOME OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800874 ENTERAL FEEDING ADAPTER KGZ ACCESSORIES, CATHETER KGZ COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Other