BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAND-AID* ARTERIAL WRIST SUPPORT

    MDR report key: 11679603 · Received April 16, 2021

    Report

    Report Number
    3014527898-2021-00001
    Event Type
    Injury
    Date Received
    April 16, 2021
    Date of Event
    June 20, 2019
    Report Date
    May 19, 2021
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    ILH
    UDI-DI
    30680651299803
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN PROCESSED FOR EVALUATION. THE FAILURE ANALYSIS LAB (FAL)RECEIVED ONE (1) UNUSED SAMPLE WITH NO PRODUCT PACKAGING. THE SAMPLE WAS EVALUATED UNDER AMBIENT LIGHT CONDITIONS. THE SAMPLE AND THE IFU ARRIVED INSIDE ITS PLASTIC BAG AND THE SAMPLE APPEARED INTACT. THE PLASTIC BAG WAS OPENED IN THE LAB AND THE SAMPLE WAS INSPECTED. THE FOAM LOOP MATERIAL WAS UNWOUND FROM THE WRIST SUPPORT. THE TWO STRIPS OF LOOP MATERIAL MEASURE APPROXIMATELY 15 INCHES. THE WHITE ARTERIAL HAND-AID STARTER BLOCK IS INSIDE THE WRIST SUPPORT. THE WHITE FOAM BLOCK WAS REMOVED. IT REVEALS THAT THE BLUE FOAM INSIDE THE WRIST SUPPORT APPEARS INDENTED WITH THE SHAPE OF THE WHITE FOAM BLOCK. ALSO OBSERVED: THE WHITE FOAM BLOCK HAS AN INDENTATION ON THE SIDE WHERE IT WAS SECURED INSIDE THE WRIST SUPPORT WHEN WRAPPED WITH THE LOOP MATERIAL. THE OPPOSITE ENDS OF THE LOOP MATERIAL ARE AFFIXED TO THE HOOK STRIP ON THE HARD WRIST SUPPORT. THEY OVERLAP EACH OTHER. THE FAL IS UNABLE TO EVALUATE THE INCIDENT REPORTED OF THE HOOK AND LOOP BEING TOO AGGRESSIVE WITH THE EVALUATION PERFORMED IN THE LAB. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. AN ASSESSMENT OF THE PRODUCTION LINE WAS PERFORMED. THE RAW MATERIAL FOAM WAS CHECKED, THE QUALITY INSPECTOR AT THE EXTERNAL SUPPLIER WAS ASKED FOR THE REPORT OF RECEIPT AND THE CERTIFICATE OF CONFORMITY. THE RAW MATERIAL WAS MADE ACCORDING TO THE SPECIFICATION, THE INSPECTION RECEIPT WAS ACCEPTED. A ROOT CAUSE WAS NOT IDENTIFIED SINCE THE RAW MATERIAL HAS NOT HAD ANY CHANGES. NO IRREGULARITIES WERE FOUND IN THE MANUFACTURING PROCESS. ALL INFORMATION REASONABLY KNOWN AS OF 08JUNE2021 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 O&M HALYARD, 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 O&M HALYARD, INC. O&M HALYARD, 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 O&M HALYARD, INC. 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 O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. UPON COMPLETION OF THE SAMPLE EVALUATION AND INVESTIGATION; A FOLLOW-UP REPORT WILL BE FILED. ALL INFORMATION REASONABLY KNOWN AS OF 15APR2021 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 O&M HALYARD, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. O&M HALYARD, 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 HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    O&M HALYARD, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3014421917-2021-00002 FOR THE SECOND PATIENT. IT WAS REPORTED BY THE CUSTOMER WHO STATED, WE ARE REACHING OUT TO YOU TO INFORM YOU OF AN ISSUE WE ARE HAVING USING YOUR ARTERIAL WRIST SUPPORT. WE HAVE HAD ISSUES WITH THEM CAUSING PRESSURE SORES BETWEEN THE THUMB AND FORE FINGER. ADDITIONAL INFORMATION WAS RECEIVED ON 9-APRIL-2021 THAT STATES, THERE WARE TWO PATIENTS WHO HAVE UNSTAGEABLE PRESSURE INJURIES. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576253 HAND-AID* ARTERIAL WRIST SUPPORT PATIENT CARE IV THERAPY SUPPORT PRODUCT ILH O&M HALYARD, INC. 29980 UNKNOWN 30680651299803

    Patients

    Seq Age Sex Outcome Treatment
    1 Other