BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP ONE STEP

    MDR report key: 11625637 · Received April 6, 2021

    Report

    Report Number
    3004932373-2021-00172
    Event Type
    Injury
    Date Received
    April 6, 2021
    Date of Event
    March 25, 2021
    Report Date
    September 14, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXF
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PR 2659127 FOLLOW UP EMDR SUBMISSION. FAILURE MODE IS NOT CONFIRMED SINCE DEFECTIVE SAMPLE WAS NOT DELIVERED AND NO PHOTOS WERE PROVIDED BY CUSTOMER. PRODUCTION BATCH HISTORY RECORDS FOR APPLICATOR MATERIAL NO.: 930599NSB BATCH NO.: 0160547 WAS REVIEWED AND NO NON-CONFORMITIES, FAILURES, DEVIATIONS, OR REWORK ACTIVITIES OCCURRED DURING THE MANUFACTURING OF THIS LOT SIMILAR TO THE REPORTED ISSUE OR THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. HOWEVER SOME OPPORTUNITIES WERE FOUND IN THE CORRECTIVE MAINTENANCE OF THE FILLING AMPOULE EQUIPMENT WHICH POTENTIALLY CAN PRODUCE BROKEN AMPOULE. CORRECTIVE MAINTENANCE WERE PERFORMED TO ELIMINATE/DECREASE BROKEN AMPULE FAILURE MODE. AWARENESS TRAINING REGARDING BROKEN AMPULE WAS PROVIDED TO PRODUCTION, ENGINEERING AND QUALITY ASSOCIATES. SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    MATERIAL NO.: 930599NSB BATCH NO.: 0160547 IT WAS REPORTED THAT GLASS SHARDS CAME OUT OF THE CHLORAPREP APPLICATOR AND CUT A PATIENT. PER SCAR: RECEIVED CUSTOMER COMPLAINT THAT GLASS SHARD WERE COMING OUT OF ONE OF THE CHLORAPREP APPLICATORS AND CUT A PATIENT. CUSTOMER IS RETURNING THE SAMPLE IF NEEDED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(6) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. ANNEX E- E1701 ABRASION. ANNEX F- F25 UNANTICIPATED ADVERSE DEVICE EFFECT. ANNEX A- A24- ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR PROBLEM USE.

    Description of Event or Problem · 1

    MATERIAL NO.: 930599NSB, BATCH NO.: 0160547. IT WAS REPORTED THAT GLASS SHARDS CAME OUT OF THE CHLORAPREP APPLICATOR AND CUT A PATIENT. PER SCAR: RECEIVED CUSTOMER COMPLAINT THAT GLASS SHARD WERE COMING OUT OF ONE OF THE CHLORAPREP APPLICATORS AND CUT A PATIENT. CUSTOMER IS RETURNING THE SAMPLE IF NEEDED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514758 CHLORAPREP ONE STEP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXF CAREFUSION 213, LLC 0113 0160547

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other