BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPAT 10FR NASOENTERIC FEEDING TUBE

    MDR report key: 6016737 · Received October 11, 2016

    Report

    Report Number
    2110851-2016-00001
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    October 16, 2015
    Report Date
    October 9, 2016
    Manufacturer
    NESTLE HEALTHCARE NUTRITION, INC.
    Product Code
    FPD
    PMA / PMN Number
    K915439
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NO LONGER BEING PRODUCED AND AFTER DEPLETION OF A SMALL AMOUNT OF CURRENT INVENTORY WILL BE DISCONTINUED. THE METALLIC TIP IS INERT AND WOULD BE NORMALLY EXCRETED. VISUAL INSPECTION OF DEVICE SHOWS DEEP DISCOLORATION TYPICALLY ASSOCIATED WITH PROLONGED USE. 10X VISUAL INSPECTION OF THE DEVICE PROVIDES EVIDENCE THAT ADHESIVE WAS APPLIED AT SEPARATION POINT INDICATING MATING COMPONENTS WERE BONDED. IT IS CONFIRMED THAT THE BOLUS TIP HAD SEPARATED FROM THE ASSEMBLY. SINCE THE BOLUS TIP WAS NOT RETURNED WITH THE DEVICE, NO ROOT CAUSE FOR THE SEPARATION CAN BE DETERMINED. REVIEWED ORIGINAL LOT INSPECTION DATA, RESULTS SHOWED ALL PASSED WITH NO ANOMALY. BASED ON THIS INFORMATION WE BELIEVE THERE IS NO DEFECT IN THE PRODUCT TO THE BEST OF OUR KNOWLEDGE.

    Additional Manufacturer Narrative · 1

    CORRECTED A TYPOGRAPHICAL ERROR MADE ON THE FIELD "DATE OF THIS REPORT". CORRECTED FROM 09-SEP-2016 TO 09-OCT-2016.

    Description of Event or Problem · 1

    NESTLE ASKED FOR MORE INFORMATION RELATED TO THE INCIDENT HOWEVER NO FURTHER INFORMATION WAS AVAILABLE AND THE ABOUT EVENT IS ALLEGED BY HOSPITAL AUTHORITIES IN (B)(6). A HYPOXIC-ISCHEMIC ENCEPHALOPATHY PATIENT WAS SELECTED FOR EXCHANGE TUBE FEELING IN THE MORNING. AFTER FEEDING, THE TUBE WAS PULLED OUT FROM THE PATIENT NOSTRIL, HOWEVER THE PRACTITIONER NOTICED THAT THE METALLIC TIP, MADE OF TUNGSTEN AT THE PROXIMAL END OF THE TUBE WAS MISSING. THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 1

    NESTLE ASKED FOR MORE INFORMATION RELATED TO THE INCIDENT HOWEVER NO FURTHER INFORMATION WAS AVAILABLE AND THE ABOUT EVENT IS ALLEGED BY HOSPITAL AUTHORITIES IN (B)(6). A HYPOXIC-ISCHEMIC ENCEPHALOPATHY PATIENT WAS SELECTED FOR EXCHANGE TUBE FEEDING IN THE MORNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670385 COMPAT 10FR NASOENTERIC FEEDING TUBE TUBE, FEEDING FPD NESTLE HEALTHCARE NUTRITION, INC. 21913V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other