BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI LITE ORANGE

    MDR report key: 11499842 · Received March 16, 2021

    Report

    Report Number
    3004932373-2021-00127
    Event Type
    Malfunction
    Date Received
    March 16, 2021
    Date of Event
    February 18, 2021
    Report Date
    June 29, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES OR PHOTOS WERE AVAILABLE FOR EVALUATION. WITH THE LACK OF SAMPLE, PROVIDED, BD WAS UNABLE TO CONFIRM THE FAILURE MODE AS THE END CAP WAS DETACHED FROM THE APPLICATOR BODY. A DEVICE HISTORY RECORD WAS REVIEWED, AND NO NON-CONFORMANCES WAS NOTED DURING THE MANUFACTURING OF THIS LOT. ALTHOUGH THE COMPLAINT COULD NOT BE CONFIRMED, THE ROOT CAUSE IS ATTRIBUTED TO THE EQUIPMENT STATION FOR THE END CAP PLACEMENT UNTO THE APPLICATOR BODY. CORRECTIVE ACTIONS WERE INITIATED WHICH LED TO BD CONDUCTING A VOLUNTARY RECALL ON CERTAIN LOTS OF THE CHLORAPREP HI- LITE ORANGE 26 ML APPLICATOR. BD HAS CONFIRMED THAT SOME OF THE PRODUCT, WHICH INCLUDED THIS LOT, HAD AN APPLICATOR END CAP THAT WAS IMPROPERLY SECURED DURING THE MANUFACTURING PROCESS WHICH RESULTED IN BROKEN GLASS DROPPING OUT OF THE APPLICATOR. YOUR FACILITY SHOULD HAVE RECEIVED A RECALL NOTIFICATION FOR THIS FAILURE, AND IT ALSO ATTACHED TO THIS EMAIL. PLEASE ENSURE THAT YOUR FACILITY COMPLETES THE CUSTOMER RESPONSE FORM ASSOCIATED WITH THE RECALL AND PROPERLY DISCARDS ANY AFFECTED PRODUCT. BD WILL REPLACE ALL DISCARDED APPLICATORS WITH UNAFFECTED BD PRODUCT . H3 OTHER TEXT: DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    MATERIAL NO.: 930815; BATCH NO.: 0327868. IT WAS REPORTED THAT THE LID OF THE APPLICATOR POPPED OFF AND THE GLASS AND LIQUID SPRAYED EVERYWHERE. PER EMAIL: THIS CALL WAS TRANSFERRED TO "TEMPE PI TECH SERVICES" QUEUE TODAY IN ERROR." HERE'S THE INFORMATION I RECEIVED COMPLAINT ON BD CHLORAPREP CATALOG #930815/LOT #0327868 CHOLR-PREP. REPORTED ISSUE: CUSTOMER STATED WHEN THE NURSE GOES TO CRACK THE HANDLE THE LID POPS OFF AND GLASS AND LIQUID SPRAYS EVERYWHERE.

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    MATERIAL NO.: 930815. BATCH NO.: 0327868. IT WAS REPORTED THAT THE LID OF THE APPLICATOR POPPED OFF AND THE GLASS AND LIQUID SPRAYED EVERYWHERE. PER EMAIL: THIS CALL WAS TRANSFERRED TO "TEMPE PI TECH SERVICES" QUEUE TODAY IN ERROR." HERE'S THE INFORMATION I RECEIVED COMPLAINT ON BD CHLORAPREP CATALOG #930815 / LOT #0327868 CHOLR-PREP. [OMITTED]. REPORTED ISSUE : CUSTOMER STATED WHEN THE NURSE GOES TO CRACK THE HANDLE THE LID POPS OFF AND GLASS AND LIQUID SPRAYS EVERYWHERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394106 CHLORAPREP ONE STEP HI LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 0327868

    Patients

    Seq Age Sex Outcome Treatment
    1 Other