BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP FREPP

    MDR report key: 12363326 · Received August 24, 2021

    Report

    Report Number
    3004932373-2021-00414
    Event Type
    Malfunction
    Date Received
    August 24, 2021
    Date of Event
    August 11, 2021
    Report Date
    December 28, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES OR PHOTOS WERE AVAILABLE FOR EVALUATION. AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE AND DETERMINE A DEFINITIVE ROOT CAUSE WITHOUT AN ACTUAL SAMPLE(S). THE PROBLEM CAN BE CAUSED BY A MIX OF FACTORS SUCH AS A BROKEN AMPOULE AND A DEFECTIVE SEAL WHICH CAN PRODUCT LOOSE GLASS IN THE PACKAGE. ACCORDING TO THE RECORDS, NO ADJUSTMENTS WERE PERFORMED TO THE SEALING EQUIPMENT AND NO QUALITY CONFORMANCES WERE FOUND. A PRODUCTION RECORD REVIEW WAS COMPLETED FOR BATCH/LOT: 1006468 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. NO FURTHER ACTIONS ARE REQUIRED. THIS FAILURE WILL CONTINUE TO BE TRACKED AND TRENDED. PATIENT IDENTIFIERS WERE PROVIDED DURING A FOLLOW UP RESPONSE. PATIENT IDENTIFIER ADDED AS ADDITIONAL INFORMATION FOR THIS SUPPLEMENTAL MDR H3 OTHER TEXT: SEE NARRATIVE BELOW.

    Additional Manufacturer Narrative · 0

    NO SAMPLES OR PHOTOS WERE AVAILABLE FOR EVALUATION. AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE AND DETERMINE A DEFINITIVE ROOT CAUSE WITHOUT AN ACTUAL SAMPLE(S). THE PROBLEM CAN BE CAUSED BY A MIX OF FACTORS SUCH AS A BROKEN AMPOULE AND A DEFECTIVE SEAL WHICH CAN PRODUCT LOOSE GLASS IN THE PACKAGE. ACCORDING TO THE RECORDS, NO ADJUSTMENTS WERE PERFORMED TO THE SEALING EQUIPMENT AND NO QUALITY CONFORMANCES WERE FOUND. A PRODUCTION RECORD REVIEW WAS COMPLETED FOR BATCH/LOT 1006468 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. NO FURTHER ACTIONS ARE REQUIRED. THIS FAILURE WILL CONTINUE TO BE TRACKED AND TRENDED. H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    MATERIAL NO: 930299, BATCH NO: 1006468.   IT WAS REPORTED THAT CDC CALLED AND SAID THAT A PIECE OF GLASS WAS IN A PACKAGE OF CHLORAPREP (SCRATCHED THE PATIENT).   CDC CALLED AND SAID THAT A PIECE OF GLASS WAS IN A PACKAGE OF CHLORAPREP (SCRATCHED THE PATIENT). (B)(4) IS THE INFOR NUMBER, REFERENCE NUMBER IS (B)(4), WITH A LOT NUMBER OF 1006468. THEY HAVE PULLED ALL THE CHLORAPREP WITH THE LOT NUMBERS. 16-AUG-2021 PER EMAIL: THANK YOU FORWARDING ADVERSE EVENT AND COMPLAINT BELOW. WE HAVE LOGGED IT UNDER (B)(4). 17-AUG-2021 PER EMAIL: THANK YOU FOR YOUR EMAIL, RECEIPT CONFIRMED. PLEASE KINDLY NOTE THAT ASSIGNED PV ID NUMBER IS (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CDC CALLED AND SAID THAT A PIECE OF GLASS WAS IN A PACKAGE OF CHLORAPREP (SCRATCHED THE PATIENT).   VERBATIM: CDC CALLED AND SAID THAT A PIECE OF GLASS WAS IN A PACKAGE OF CHLORAPREP (SCRATCHED THE PATIENT). 542977 IS THE INFOR NUMBER, REFERENCE NUMBER IS 930299, WITH A LOT NUMBER OF 1006468. THEY HAVE PULLED ALL THE CHLORAPREP WITH THE LOT NUMBERS. 16-AUG-2021 PER EMAIL: THANK YOU FORWARDING ADVERSE EVENT AND COMPLAINT BELOW. WE HAVE LOGGED IT UNDER MIQ-08162021-1437. 17-AUG-2021 PER EMAIL: THANK YOU FOR YOUR EMAIL, RECEIPT CONFIRMED. PLEASE KINDLY NOTE THAT ASSIGNED PV ID NUMBER IS (B)(4).

    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

    IT WAS REPORTED THAT CDC CALLED AND SAID THAT A PIECE OF GLASS WAS IN A PACKAGE OF CHLORAPREP (SCRATCHED THE PATIENT).   VERBATIM: CDC CALLED AND SAID THAT A PIECE OF GLASS WAS IN A PACKAGE OF CHLORAPREP (SCRATCHED THE PATIENT). (B)(4) IS THE INFO NUMBER, REFERENCE NUMBER IS 930299, WITH A LOT NUMBER OF 1006468. THEY HAVE PULLED ALL THE CHLORAPREP WITH THE LOT NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1260403 CHLORAPREP ONE STEP FREPP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 1006468

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male Other