BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDLINE ENTRAFLO GASTROSTOMY FEEDING TUBE

    MDR report key: 7116385 · Received December 14, 2017

    Report

    Report Number
    8030107-2017-00002
    Event Type
    Injury
    Date Received
    December 14, 2017
    Date of Event
    June 26, 2017
    Report Date
    December 6, 2017
    Manufacturer
    DEGANIA SILICONE LTD
    Product Code
    PIF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL SAMPLE FROM THE CUSTOMER'S COMPLAINT REPORTED TO BE UNAVAILABLE. WE DID RECEIVE THE PICTURE OF THE ACTUAL DEVICE INSIDE THE PATIENT, THE PICTURE WAS MADE DURING THE GASTRODUODENOSCOPY PROCEDURE. NOTE: THE LOT NUMBER # 94505 PROVIDED BY THE INITIAL REPORTER IS NOT THE LOT OF DEGANIA AND DOES NOT LOOK SIMILAR TO LOT NUMBERS UTILISED BY DEGANIA. THE USER INDICATED THAT GASTRIC ULCER LIKELY BEING CAUSED FROM A PROTRUDING PLASTIC DEVICE AT THE END OF THE PEG TUBE, WHICH IS CAUSING TRAUMA TO GASTRIC MUCOSA. DEGANIA'S PEG TUBE DOES NOT HAVE PLASTIC PARTS ON ITS END; IT IS MADE FROM SOFT SILICONE MATERIAL. THE DEVICE ON THE PICTURE PROVIDED BY THE CUSTOMER DOES LOOK LIKE DEVICE PRODUCED BY DEGANIA. HOWEVER THE BALLOON OF THE PEG TUBE WHICH HOLDS THE DEVICE INSIDE OF THE PATIENT ON THE PICTURE LOOKS TO BE INFLATED MUCH LESS THEN IT SHOULD BE (15 CC). IF THE BALLOON IS NOT INFLATED TO ITS NOMINAL VOLUME, IT CAUSES THE SHAFT'S END TO PROTRUDE MORE THEN WHEN THE BALLOON IS FULLY INFLATED. THE CURRENTLY PRODUCED PARTS WERE INSPECTED AND FOUND TO BE OK REGARDING THEIR SPECIFICATION. WE HAVE NO REASONS TO SUGGEST THAT THE DEVICE SEEN ON THE PICTURE DEVIATES FROM ITS SPECIFICATION.

    Description of Event or Problem · 1

    INITIAL NOTIFICATION FROM OUR CUSTOMER MEDLINE INC. ON 11.08.2017: "PHONE CALL PLACED TO (B)(6), CUSTOMER'S WIFE, WHO REPORTED THAT HER HUSBAND, (B)(6), HAD A FEEDING TUBE PUT IN (B)(6) 2016 (NOT A MEDLINE INDUSTRIES, INC. TUBE). (B)(6) REPORTED THAT IN (B)(6) 2017 THE STOPPER ON THE TUBE CRACKED AND SHE HAD TO HAVE THE TUBE REPLACED. (B)(6) STATED THAT THE DOCTOR REPLACED THE TUBE WITH A MEDLINE INDUSTRIES, INC. TUBE AND THE PATIENT WAS DISCHARGED. A WEEK LATER, (B)(6) STATED THAT SHE WAS CHECKING (B)(6)'S RESIDUAL AND SHE EXTRACTED COFFEE GROUND RESIDUAL. (B)(6) WAS TAKEN TO THE HOSPITAL AND UNDERWENT AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE WHERE THE SURGEON DISCOVERED A GASTRIC ULCER. ACCORDING TO THE WIFE, THE MEDLINE INDUSTRIES, INC. BALLOON THAT HOLDS THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE IN PLACE WAS NOT INFLATED AND WAS RUBBING AGAINST GASTRIC MUCOSA WHICH WAS CAUSING THE ULCER. THE PEG TUBE WAS REPLACED WITH A DIFFERENT TUBE WITHOUT FURTHER INCIDENT. DUE TO THE REPORTED INCIDENT AND SUBSEQUENT NEED FOR MEDICAL INTERVENTION, THIS IS AN MDR REPORTABLE EVENT. A SAMPLE IS AVAILABLE AND HAS BEEN REQUESTED TO BE RETURNED FOR EVALUATION." UPDATE FROM MEDLINE INC. ON 11.17.2017: "WE DO NOT HAVE A SAMPLE THAT CAN BE SENT FOR EVALUATION". THE LOT NUMBER # 94505 PROVIDED BY MEDLINE IS NOT DEGANIA'S LOT NUMBER AND DOES NOT LOOK LIKE LOT NUMBERS UTILIZED BY DEGANIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898064 MEDLINE ENTRAFLO GASTROSTOMY FEEDING TUBE GASTROSTOMY FEEDING TUBE PIF DEGANIA SILICONE LTD 22FR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R