BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRAWFORD INTUB SET .8MMTIP 145MM 544MM

    MDR report key: 11068668 · Received December 23, 2020

    Report

    Report Number
    2916714-2020-00725
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Report Date
    March 4, 2021
    Product Code
    HNW
    UDI-DI
    04046964686238
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ON-SITE EVALUATION OF THE UNIT WAS PERFORMED AND NO PARTS WERE RETURNED FOR FAILURE ANALYSIS. THEREFORE, THE INVESTIGATION WAS NOT ABLE TO CONFIRM A DEVICE ISSUE THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS NOT ABLE TO BE CONDUCTED BY THE MANUFACTURER AS THE LOT # OF THE DEVICE IN QUESTION WAS NOT KNOWN. HOWEVER, ALL DEVICE HISTORY RECORDS (DHR) ARE REVIEWED AND RELEASED ACCORDING TO DOCUMENTED PROCEDURES AND A DEVICE IS NOT RELEASED IF IT DOES NOT MEET REQUIREMENTS OR IS NONCONFORMING. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. A VISUAL EXAMINATION OF THE DEVICE WAS PERFORMED WHICH REVEALED THAT THE STYLET WAS NOT CONNECTED TO THE TUBING. REPORTEDLY, THE STYLET WAS RETURNED INSIDE THE PACKAGING WITH A LABEL THAT STATED "SINGLE USE," WHICH WAS ASSUMED TO REFERENCE THE SILICON TUBING. THE RETURNED TUBING WAS THE INCORRECT SIZE AND WAS FOUND TO BE THINNER AND MORE DELICATE THAN THE DEVICE TUBING. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE USER ERROR.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO AESCULAP THAT A CRAWFORD INTUBATION SET (PART # MA922R) WAS USED DURING A MEETING WITH THE SALES REPRESENTATIVE TO INSPECT AND FUNCTIONALLY TEST THE DEVICE. ACCORDING TO THE COMPLAINANT, A NEW DEVICE THAT HAD BEEN PROCESSED WAS USED AS AN EXAMPLE, AND UPON PULLING THE STYLET, IT DETACHED AND THE TUBING BROKE. THE DEVICE WAS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT YET BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1533984 CRAWFORD INTUB SET .8MMTIP 145MM 544MM DILATOR, LACHRYMAL HNW MA922R 04046964686238

    Patients

    Seq Age Sex Outcome Treatment
    1