BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP SWABSTICK

    MDR report key: 11261789 · Received February 1, 2021

    Report

    Report Number
    3004932373-2021-00017
    Event Type
    Injury
    Date Received
    February 1, 2021
    Date of Event
    January 20, 2021
    Report Date
    March 31, 2021
    Manufacturer
    CAREFUSION, INC
    Product Code
    KXF
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES OR PHOTOS ARE AVAILABLE FOR EVALUATION. UNFORTUNATELY, AS A RESULT, BD IS UNABLE TO VERIFY THE REPORTED ISSUE OR DEFINE A PROBABLE ROOT CAUSE. PRODUCTION RECORD REVIEW WAS COMPLETED FOR BATCH/LOT 0059490 AND THERE WERE NO NON-CONFORMANCES RECORDED DURING THE MANUFACTURING OF THE LOT. FURTHERMORE, CHEMISTRY AND MICROBIOLOGY RESULTS FOR SOLUTION PN 0-710282 (USED IN PRODUCT 260100 BATCH 005940) WERE REVIEWED AND THEY WERE ALL WITHIN SPECIFICATION. THERE WERE NO FINDINGS IN THESE REVIEWS THAT WOULD INDICATE ANY CONTRIBUTION TO THE DEFECT REPORTED. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. THIS FAILURE MODE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED 10 PATIENTS EXPERIENCED RASHES IN THE VENIPUNCTURE AREA USING CHLORAPREP. PER EMAIL: MY NAME IS [OMITTED] AND I AM THE DIRECTOR AT (B)(6). WE ARE A BLOOD DONATION CENTER IN (B)(6) THAT HAS LONG USED CHLORAPREP PRODUCTS. RECENTLY, WE ADOPTED KITTING THROUGH MEDLINE AND WE REPORTED AROUND 10 DONORS WHOM EXPERIENCED RASHES IN THE VENIPUNCTURE AREA FOLLOWING PHLEBOTOMY. ATTACHED IS THE DOCUMENTATION REGARDING THE LOT OF SWABS THAT WE WERE PROVIDED TO US BY MEDLINE. HAS THIS ISSUE BEEN REPORTED TO YOU ALREADY? HAVE YOU SEEN ISSUES WITH THIS LOT?

    Additional Manufacturer Narrative · 1

    (B)(6) 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.: 260100, BATCH NO.: 0059490. IT WAS REPORTED 10 PATIENTS EXPERIENCED RASHES IN THE VENIPUNCTURE AREA USING CHLORAPREP. PER EMAIL: MY NAME IS [OMITTED] AND I AM THE DIRECTOR AT INOVA BLOOD DONOR SERVICES. WE ARE A BLOOD DONATION CENTER IN STERLING, VA THAT HAS LONG USED CHLORAPREP PRODUCTS. RECENTLY, WE ADOPTED KITTING THROUGH MEDLINE AND WE REPORTED AROUND 10 DONORS WHOM EXPERIENCED RASHES IN THE VENIPUNCTURE AREA FOLLOWING PHLEBOTOMY. ATTACHED IS THE DOCUMENTATION REGARDING THE LOT OF SWABS THAT WE WERE PROVIDED TO US BY MEDLINE. HAS THIS ISSUE BEEN REPORTED TO YOU ALREADY? HAVE YOU SEEN ISSUES WITH THIS LOT?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160722 CHLORAPREP SWABSTICK 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXF CAREFUSION, INC 0059490

    Patients

    Seq Age Sex Outcome Treatment
    1 Other