BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL

    MDR report key: 2033640 · Received February 11, 2011

    Report

    Report Number
    1037905-2011-00070
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    WILSON-COOK MEDICAL, INC.
    Product Code
    KNT
    PMA / PMN Number
    K920703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: A PRODUCT EVAL WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVAL. THE REPORT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. A SAMPLE TEST FROM THIS LOT COULD NOT BE CONDUCTED BECAUSE NONE OF THE PRODUCT FROM THIS LOT REMAINED IN INVENTORY. A REVIEW OF THE 12 MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVAL. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. THE INFO RELATED TO BLOOD IN THE THROAT WAS REVIEWED WITH CLINICAL PERSONNEL. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION, AND THIS DID NOT REQUIRE MEDICAL OR SURGICAL INTERVENTION. THE PRESENCE OF BLOOD CAN OCCUR DURING PLACEMENT OF A FEEDING TUBE. THE INSTRUCTIONS FOR USE FOR THE FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET LISTS ESOPHAGEAL INJURY AND HEMORRHAGE AS POTENTIAL COMPLICATIONS ASSOCIATED WITH PLACEMENT OF A PEG TUBE. WE REQUESTED INFO RELATED TO THE LENGTH OF THE INCISION MADE IN THE ABDOMEN, BUT THIS INFO COULD NOT BE PROVIDED. DIFFICULTY PASSING THE GASTROSTOMY TUBE THROUGH THE INCISION SITE CAN OCCUR IF THE INCISION THROUGH THE SKIN IS LESS THAN 1 CM IN LENGTH OR DOES NOT COMPLETELY PENETRATE THE ABDOMINAL WALL INTO THE STOMACH. THE INSTRUCTIONS FOR USE FOR THIS PRODUCT INSTRUCT THE USER TO MAKE A 1 CM INCISION TO FACILITATE PASSAGE OF THE FEEDING TUBE. A SMALLER OR INCOMPLETE INCISION MAY CAUSE RESISTANCE WHEN THE GASTRONOMY TUBE EXITS THE INCISION SITE. INADEQUATE LUBRICATION OF THE FEEDING TUBE PRIOR TO PLACEMENT COULD CONTRIBUTE TO DIFFICULTY PASSING THE GASTROSTOMY TUBE THROUGH THE INCISION SITE AND SUBSEQUENT TUBE SEPARATION. THE INSTRUCTION FOR USE FOR THIS PRODUCT LINE INSTRUCTS THE USER TO LUBRICATE THE TUBE THOROUGHLY AND OVER THE ENTIRE LENGTH. THIS ACTIVITY WILL AID IN SMOOTH FEEDING TUBE PLACEMENT. PRIOR TO DISTRIBUTION, ALL FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SETS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MFG REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: THIS TYPE OF OCCURRENCE HAS BEEN BROUGHT TO THE ATTENTION OF THE APPROPRIATE INTERNAL PERSONNEL IN AN EFFORT TO HEIGHTEN AWARENESS. NO FURTHER ACTION WARRANTED AT THIS TIME BECAUSE THE REPORT WAS UNABLE TO BE VERIFIED. THE COMPLAINT RISK PRIORITY NUMBER (CRPN) FOR THIS TYPE OF OCCURRENCE HAS BEEN CALCULATED BASED ON THE RATE OF OCCURRENCE AND SEVERITY OF THE OUTCOME. BASED ON THIS ACTIVITY, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE. CUSTOMER QA WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING FEEDING TUBE PLACEMENT, THE PHYSICIAN USED A COOK FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL. THE PHYSICIAN INDICATED THE TAPERED SECTION OF THE FEEDING TUBE CAUGHT IN THE PT'S MOUTH AND AGAIN AT THE INCISION SITE, CREATING RESISTANCE IN FEEDING TUBE PLACEMENT. THE FEEDING TUBE WAS ABLE TO BE PLACED SUCCESSFULLY. BLOOD WAS OBSERVED IN THE PT'S THROAT. THIS WAS REPORTEDLY CAUSED BY THE TAPERED SECTION OF THE FEEDING TUBE. THE BLOOD OBSERVED DID NOT REQUIRE MEDICAL ATTENTION OR INTERVENTION. THE PT WAS REPORTED TO BE "FINE". A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES) KNT WILSON-COOK MEDICAL, INC. W2937603

    Patients

    Seq Age Sex Outcome Treatment
    1