BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLOON SLG 16 FR X 2.3 CM

    MDR report key: 15419139 · Received September 14, 2022

    Report

    Report Number
    9612030-2022-03387
    Event Type
    Malfunction
    Date Received
    September 14, 2022
    Date of Event
    August 24, 2022
    Report Date
    November 28, 2022
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD WAS REVIEWED. NO ABNORMAL PROCESS CONDITIONS WERE PRESENT DURING THE MANUFACTURING OF THE PRODUCT THAT COULD HAVE LED TO THE REPORTED ISSUE. THE DEVICE HISTORY RECORD REVIEW SHOWED THAT ALL ACCEPTANCE CRITERIA INSPECTIONS PER ESTABLISHED SAMPLING LEVELS WERE WITHIN ACCEPTABLE LIMITS DURING THE PRODUCTION PROCESS. THE PRODUCT WAS MANUFACTURED ON 14-FEB-2018. A SAMPLE HAVE NOT YET BEEN RECEIVED AT THE MANUFACTURING SITE FOR INVESTIGATION. BECAUSE A SAMPLE WAS NOT RETURNED, WE WERE UNABLE TO PERFORM A FOLLOW-UP INVESTIGATION TO INCLUDE FUNCTIONAL AND VISUAL EVALUATIONS TO CONFIRM THE ISSUE AND ROOT CAUSE ANALYSIS. SINCE THE DEVICE IS PROVIDED BY AN EXTERNAL SUPPLIER, A CORRECTIVE ACTION (CAPA) HAS BEEN GENERATED TO THE SUPPLIER TO DETERMINE THE ROOT CAUSE AND CORRECTIVE AND PREVENTIVE ACTIONS, IF REQUIRED. THIS COMPLAINT WILL BE USED FOR TRACING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 0

    SECTION B5 HAS BEEN UPDATED TO INCLUDE ADDITIONAL INFORMATION RECEIVED ALONG WITH THE RETURNED DEVICE. THE DEVICE HISTORY RECORD WAS REVIEWED. NO ABNORMAL PROCESS CONDITIONS WERE PRESENT DURING THE MANUFACTURING OF THE PRODUCT THAT COULD HAVE LED TO THE REPORTED ISSUE. THE DEVICE HISTORY RECORD REVIEW SHOWED THAT ALL ACCEPTANCE CRITERIA INSPECTIONS PER ESTABLISHED SAMPLING LEVELS WERE WITHIN ACCEPTABLE LIMITS DURING THE PRODUCTION PROCESS. THE PRODUCT WAS MANUFACTURED ON 14-FEB-2018. THE DEVICE WAS RECEIVED FOR EVALUATION AND THE REPORTED CONDITION HAS BEEN CONFIRMED. A CORRECTIVE AND PREVENTIVE ACTION HAS BEEN INITIATED TO ADDRESS THE REPORTED ISSUE. THE ROOT CAUSE AND THE ACTION PLAN WILL BE DOCUMENTED THROUGH CAPA. SECTION H6 (HEALTH EFFECT - CLINICAL CODE): ORIGINALLY REPORTED AS 4582 NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS AND SHOULD BE 4545 SKIN INFLAMMATION/ IRRITATION BASED ON THE INFORMATION RECEIVED ALONG WITH THE RETURNED DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED HOLE IN THE BALLOON. THE BALLOON WAS INITIALLY PLACED ON (B)(6) 2022. THERE WAS NO PATIENT HARM REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED HOLE IN THE BALLOON. THE BALLOON WAS INITIALLY PLACED ON (B)(6) 2022. THERE WAS NO PATIENT HARM REPORTED. PER ADDITIONAL INFORMATION RECEIVED PINHOLE IN THE BALLOON CAUSED DISLODGEMENT AND SITE IRRITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2745600 BALLOON SLG 16 FR X 2.3 CM TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CARDINAL HEALTH 716230 1833804264

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown