BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JEJUNAL FEEDING TUBE SET

    MDR report key: 3101983 · Received April 22, 2013

    Report

    Report Number
    1037905-2013-00163
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 23, 2013
    Report Date
    March 23, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNT
    PMA / PMN Number
    K920703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. PRIOR TO DISTRIBUTION, ALL JEJUNAL FEEDING TUBE ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: HEIGHTENED AWARENESS TRAINING HAS BEEN CONDUCTED IN REGARD TO THE NONCONFORMANCE ASSOCIATED WITH THE RETURNED DEVICE. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED AND THIS REPRESENTS AN UNUSUAL OCCURRENCE. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 1

    PRODUCT BACKGROUND: THE JEJUNAL FEEDING TUBE IS PLACED THROUGH THE INNER LUMEN OF AN EXISTING PEG (PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE). THE PATIENT IS GIVEN FOOD AND MEDICATION THROUGH TWO DIFFERENT LINES IN THE JEJUNAL FEEDING TUBE. MEDICATION IS ADMINISTERED THROUGH THE LINE THAT EMPTIES INTO THE STOMACH (G-TUBE IS PRINTED ON THE GASTRIC PORT LINE). NUTRITION FEED IS GIVEN THROUGH THE LINE THAT EMPTIES INTO THE SMALL BOWEL (J-TUBE IS PRINTED ON THE JEJUNAL PORT LINE). ON APPROXIMATELY ON (B)(6) 2013, THE SURGEON PLACED ANOTHER MANUFACTURER'S PEG (PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE) WITH A COOK JEJUNAL FEEDING TUBE IN THE PATIENT. THE PATIENT HAD ENCOUNTERED WOUND HEALING PROBLEMS AND DIFFICULTY RECEIVING NUTRITION. THE PEG FROM ANOTHER MANUFACTURER MIGRATED IN TO THE ABDOMINAL WALL. ON APPROXIMATELY ON (B)(6) 2013, THE MIGRATED PEG DEVICE AND COOK JEJUNAL FEEDING TUBE WERE REMOVED. A NEW PEG FROM ANOTHER MANUFACTURER AND A NEW COOK JEJUNAL FEEDING. TUBE WERE PLACED BY THE SURGEON. WHILE THE SURGEON WAS OUT OF TOWN, THE PATIENT'S FEEDS HAD BEEN OFF MORE THAN ON BECAUSE THE FEEDINGS INSTILLED THROUGH THE COOK JEJUNAL FEEDING TUBE (J-TUBE LINE) HAD LEAKED EXCESSIVELY OUT AROUND A LOOSE TUBE TRACT ONTO THE SHEETS (WHERE THE PEG IS LOCATED IN THE ABDOMEN). MEDICATIONS THAT WERE GIVEN THROUGH THE COOK JEJUNAL FEEDING TUBE AT THE G-TUBE LINE HAD CLOGGED IT TO THE POINT THAT THE SYSTEM NEEDED REPLACEMENT. SEE MDR 1037905-2013-00163. IN THE SURGEON'S ABSENCE, A GASTROENTEROLOGIST REPLACED THE COOK JEJUNAL FEEDING TUBE. ONE OF THE SURGEON'S RESIDENTS RECOGNIZED THAT IN ORDER FOR THE J-TUBE LINE FEEDINGS TO LEAK AROUND THE PEG TRACT IN THE PATIENT'S STOMACH, THE ICU NURSING STAFF MUST HAVE CONFUSED THE TWO PORTS. THEY BELIEVED THE ICU NURSING STAFF WERE FEEDING THE G-TUBE LINE AND CLOGGING THE J-TUBE LINE BY PUTTING CRUSHED PILLS THROUGH IT. UPON FURTHER EXAMINATION OF THE CURRENT JEJUNAL FEEDING TUBE, THE RESIDENT DISCOVERED THAT THE J-TUBE AND G-TUBE PORTS WERE PROPERLY LABELED AND COLOR-CODED, BUT WERE IN FACT ATTACHED TO THE INCORRECT LINE (SWITCHED). THE SURGEON'S RESIDENT RE-EDUCATED THE ICU NURSING TEAM. TEMPORARY TAPE LABELS WERE APPLIED BY THE NURSING STAFF SO THAT THE CORRECT PORTS COULD BE IDENTIFIED. ON APPROXIMATELY ON (B)(6) 2013, THE PATIENT'S PEG MIGRATED AGAIN. WHEN THE SURGEON REPLACED IT, IT WAS CONFIRMED DIRECTLY BY THE SURGEON THAT THE JEJUNAL AND GASTRIC PORTS OF THE COOK JEJUNAL FEEDING TUBE WERE REVERSED. SEE MDR 1037905-2013-00164. THE SURGEON PRESUMES BUT CANNOT KNOW FOR SURE THAT THE PREVIOUS TUBE THAT LEAKED AND CLOGGED HAD BEEN SIMILARLY INCORRECT. THIS PATIENT'S PEG TUBE TRACT IN THE ABDOMEN WAS DESCRIBED AS EXPANDED AND POORLY-HEALING. THE SURGEON INDICATED THAT THIS WILL REQUIRE RELIABLE NUTRITION TO HEAL. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. OTHER THAN REPLACING THE J-TUBE EXTENSION WITH A DIFFERENT ONE, THERE WERE NO ADDITIONAL PROCEDURES REQUIRED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE THOUGH IT DID PROLONG THE PATIENT'S NEED FOR A J-TUBE BY HAVING INTERRUPTED TUBING USAGE. OF THE TWO (2) DEVICES DESCRIBED, ONLY ONE (1) DEVICE WAS MADE AVAILABLE FOR EVALUATION. 1037905-2012-00163: NOT AVAILABLE FOR EVALUATION, 1037905-2012-00164: RETURNED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171771 JEJUNAL FEEDING TUBE SET KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES) KNT WILSON-COOK MEDICAL INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 REQUEST BOSTON SCIENTIFIC PEG KIT| OLYMPUS ENDOSCOPE (UNKNOWN MODEL NUMBER)