BEUDAMED
    FDA Adverse Event Other Summary report: N

    12FR X2.0CM ENTRISTAR SLG X1

    MDR report key: 1011984 · Received March 11, 2008

    Report

    Report Number
    1314412-2008-00008
    Event Type
    Other
    Date Received
    March 11, 2008
    Report Date
    February 11, 2008
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER HOSPITAL (NO TITLE OR NAME INCLUDED): "PT HAS HAD AN ENTRISTAR SKIN LEVEL DEVICE PLACED INSTEAD OF HIS FREKA PEG TUBE IN 2007 BY CONSULTANT PEDIATRIC SURGEON HERE AT THE HOSPITAL. THE MOTHER TOLD ME ON FOUR MONTHS EARLIER THAT THE ENTRISTAR STARTED TO LEAK FROM THE VALVE A WEEK AGO AND THAT SHE HAS BEEN UP TO THE A&E DEPARTMENT FOR ASSESSMENT, HOWEVER, IT DIDN'T LEAK WHEN IT WAS FLUSHED WITH WATER. EVEN SO, IT CONTINUED TO LEAK OVERNIGHT WHEN THE PT WAS CONNECTED TO A CONTINUOUS FEEDING. ACCORDING TO THE CS SPECIALIST NURSE, WHO DID A HOME VISIT SHE WAS CONCERNED THAT IT LEAKED. PT WAS REFERRED TO CONSULTANT SURGEON AGAIN ON 10/10/2007, TO REVIEW BUTTON WITH A VIEW TO REPLACE THE THE FOLLOWING DAY. I SPOKE TO THE LOCAL TYCO NUTRITION NURSE, SHE GOT THE MESSAGE I LEFT FOR HER THE PREVIOUS WEEK, BUT HAD NOT RETURNED MY CALL. I WANTED HER TO DO A HOME VISIT TO GET AN OBJECTIVE PROSPECTIVE ON THE LEAKY VALVE, BUT SHE WAS UNABLE TO DO SO AS SHE WAS GOING ON A TRAINING COURSE THE NEXT DAY. SHE HAD SUGGESTED THAT WHEN THE BUTTON IS REPLACED, WE SHOULD SEND IT TO THE COMPANY FOR INSPECTION. PT ATTENDED CLINIC AGAIN ON SIX DAYS LATER, WHERE HE WAS SEEN BY PHYSICIANS WHO WAS GOING TO CHASE UP APPOINTMENT WITH SURGEONS FOR CHANGE OF ENTRISTAR TO ANOTHER ONE. PT'S ENTRISTAR WAS CHANGED ON THE FOLLOWING MONTH. UNFORTUNATELY, THE PREVIOUS ENTRISTAR GOT DISCARDED. MOTHER PHONED ME ON THE NEXT MONTH, INFORMED ME THAT THE REPLACEMENT ENTRISTAR WAS NOW LEAKING AGAIN. I ATTENDED THE CLINIC WITH THE PT AND MOTHER ON THE NEXT DAY. WE HAD A LONG DISCUSSION ABOUT THE OPTIONS SINCE THE SECOND ENTRISTAR HAS LEAKED. PT WAS REFERRED AGAIN FOR REPLACEMENT OF THE ENTRISTAR TO A FREKA PEG HE IS GOING TO HAVE IT REPLACED IN 2008. THE SECOND ENTRISTAR DEVICE WILL BE KEPT AND SENT TO TYCO FOR INSPECTION WITH THIS FORM. PER CONSULTANT PEDIATRICIAN:" THESE TWO EPISODES OF A MALFUNCTIONING GASTROSTOMY DEVICE ARE VERY UNFORTUNATE FOR PT. THE PARENTS FEEL THAT HE HAS BECOME VERY WORRIED ABOUT THE LEAK AND THAT IT MAY BE HIS FAULT. CYSTIC FIBROSIS IS A CONDITION WHICH PUTS A HUGE BURDEN ON CHILDREN AND FAMILIES. PHYSIOLOGICAL PROBLEMS ARE ALREADY MORE COMMON. HIS RESPONSE TO THIS EQUIPMENT FAILURE WILL POTENTIALLY AGGRAVATE HIS PHYSIOLOGICAL STRESS. HE HAS NEED TWO EXTRA GENERAL ANESTHESIA TO REPLACE THE DEVICES. BECAUSE ANESTHESIA MAY COMPROMISE LUNG FUNCTION IN CF PTS WHO HAVE SIGNIFICANT LUNG PATHOLOGY, THESE EXTRA ANESTHESIAS WILL HAVE BEEN AN EXTRA STRESS TO HIS LUNG FUNCTION AND MAY PRECIPITATE SUBSEQUENT LUNG INFECTION. FINALLY, IN A PT WHOSE NUTRITION IS ALREADY COMPRISED (HENCE THE NEED FOR THE GASTROSTOMY) THE LOSS OF EXTRA NUTRITION FROM THE LEAK, WILL HAVE COMPROMISED HIS NUTRITIONAL STATUS EVEN FURTHER. IN CONCLUSION, THE FAULTY ENTRISTAR DEVICES HAVE HAD A SIGNIFICANTLY HARMFUL EFFECT ON THE BOY'S PHYSIOLOGICAL AND PHYSICAL WELL BEING."

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTH CARE/KENDALL IN 2008 THAT A CUSTOMER HAD A PROBLEM WITH A SKIN LEVEL GASTROSTOMY TUBE. THE CUSTOMER STATED THAT A BOY AGED 8 THAT SUFFERS FROM CYSTIC FIBROSIS- HAD ENTRISTAR PLACED IN 2007, IT STARTED TO LEAK FROM THE VALVE IN THE FOLLOWING MONTH, SO THE ENTRISTAR WAS REPLACED IN TWO MONTHS LATER. IN THE FOLLOWING MONTH, THE NEW ENTRISTAR STARTED TO LEAK. THIS RESULTED IN THE CHILD HAVING TO HAVE TWO GENERAL ANAESTHETICS TO REPLACE THE DEVICES. PLEASE SEE ATTACHED COMPLAINT FORM FOR FULL DETAILS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12FR X2.0CM ENTRISTAR SLG X1 SKIN LEVEL GASTROSTOMY TUBE KNT TYCO HEALTHCARE/KENDALL 8884741220 602411

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR