BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT WITH ENFIT CONNECTORS - 20 FR -

    MDR report key: 15372662 · Received September 7, 2022

    Report

    Report Number
    9611594-2022-00115
    Event Type
    Malfunction
    Date Received
    September 7, 2022
    Report Date
    October 7, 2022
    Manufacturer
    AVENT SA DE R.L. DE C.V. (AVENT 1)
    Product Code
    BSY
    UDI-DI
    00350770446165
    PMA / PMN Number
    K924065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL SAMPLE FROM THE REPORTED EVENT WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION OF THE DEVICE REVEALED: THE SAMPLE TUBE APPEARED CUT BETWEEN 6 AND 4CM MARKING AND THERE WERE NO OBVIOUS DEFECTS SEEN ON THE BUMPER COMPONENT AREA. INSPECTION OF THE BUMPER UNDER MAGNIFICATION (20X) REVEALED, THERE WAS NO EXCESSIVE MATERIAL BUILD-UP AROUND THE BUMPER'S TOP, BOTTOM AND SIDE PORTIONS. THE BUMPER WAS FELT WITH GLOVED FINGERS: NO BURRS OR JAGGED EDGES FELT AT THE SURFACE AND THERE WAS NO OBVIOUS BIOLOGICAL MATTER(S) FOUND ON THE OUTER PORTION OF THE TUBING AND BUMPER (PRIOR TO DECONTAMINATION); NO OBVIOUS DEFECTS WERE IDENTIFIED ON THE DEVICE. THE CAUSE OF THE ISSUE APPEARED TO BE LACK OF LUBRICANT ON THE SKIN AND TUBE AROUND THE STOMA WITH THE WATER-SOLUBLE LUBRICANT; THE ROOT CAUSE IS USER: INCORRECT USE. ALL INFORMATION REASONABLY KNOWN AS OF 04 OCT 2022 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL INC.. AVANOS MEDICAL INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE INITIAL MEDWATCH REPORT WAS SUBMITTED USING, 2026095-2022-00068; NEW INFORMATION RECEIVED ON 08AUG2022 REPORTED THE MANUFACTURING SITE AS 9611594-2022-00115. ALL FUTURE MW(S) FOR THIS REPORT WILL BE SUBMITTED USING 9611594-2022-00115; NO FURTHER INFORMATION WILL BE SUBMITTED UNDER: 2026095-2022-00068. THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR LOT 30171330 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 07 SEP 2022 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL INC.. AVANOS MEDICAL INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    THE REPORT WAS INITIALLY RECEIVED ON 23JUN2022.

    Description of Event or Problem · 0

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT UNITS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2022-00068 FOR THE FIRST REPORT. IT WAS REPORTED THAT THE GASTROINTESTINAL (GI) PHYSICIAN WAS UNABLE TO REMOVE THE TUBE FROM THE PATIENT AS PER NORMAL PROCEDURE AND HAD TO CUT THE TUBE; THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 30JUN2022 REPORTED THAT THE TUBE WAS PLACED ON (B)(6) 2022; THERE WAS NO REPORTED INJURY ADDITIONAL INFORMATION RECEIVED 01JUL2022 REPORTED THE TUBE WAS IN PLACE FOR 6 WEEKS AND CONFIRMED THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED 18JUL2022 THE TUBE WAS REMOVED ENDOSCOPICALLY; THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2618776 MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT WITH ENFIT CONNECTORS - 20 FR - DH EF PEG INITIAL PLACEMENT PRODUCTS BSY 8150-20 30171330 00350770446165

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown