BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP SEPP

    MDR report key: 11711456 · Received April 22, 2021

    Report

    Report Number
    3004932373-2021-00209
    Event Type
    Injury
    Date Received
    April 22, 2021
    Date of Event
    March 24, 2021
    Report Date
    July 30, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO PHOTOS OR SAMPLES WERE AVAILABLE FOR EVALUATION. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DEFINE A ROOT CAUSE. IF SAMPLES OR PHOTOS BECOME AVAILABLE, THIS RECORD WILL BE RE-OPENED AND RE-ASSESSED. PRODUCTION RECORD REVIEW WAS COMPLETED FOR BATCH/LOT 8264564 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 ACTION WILL BE TAKEN BASED ON NO ADVERSE TREND OBSERVED AND WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO MEMBERS OF THE STAFF HAVE HAD A SHARPS INJURY DUE TO THE GLASS BREAKING THROUGH THE PLASTIC. PER COMPLAINT FORM: I SPOKE TO HELEN ON THE PHONE THEY ARE IN RADIOLOGY AND USED THE CHLORAPREP SEPP THAT IS PART OF THE ROCIALLE CANNULATION PACK THAT IS USED IN WALES. THEY HAVE USED THE PRODUCT FOR A LONG TIME BUT TWO MEMBERS OF STAFF HAVE HAD A SHARPS INJURY DUE TO THE GLASS BREAKING THROUGH THE PLASTIC. ALSO BELOW PLEASE SEE THE INITIAL COMMUNICATION SENT TO ME VIA THE PRODUCT MANAGER. CONTACT INFO OMITTED. BUSINESS UNIT: INFECTION PREVENTION . PRODUCT LINE: CHLORAPREP. ENQUIRY: A COUPLE OF MY STAFF AND CUT THEIR FINGERS RECENTLY USING CHLORAPREP SEPP 0.67ML. THIS COULD BE A BATCH ISSUE? BATCH NUMBER 8264564.

    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 TWO MEMBERS OF THE STAFF HAVE HAD A SHARPS INJURY DUE TO THE GLASS BREAKING THROUGH THE PLASTIC. PER COMPLAINT FORM: I SPOKE TO (B)(6) ON THE PHONE THEY ARE IN RADIOLOGY AND USED THE CHLORAPREP SEPP THAT IS PART OF THE ROCIALLE CANNULATION PACK THAT IS USED IN WALES. THEY HAVE USED THE PRODUCT FOR A LONG TIME BUT TWO MEMBERS OF STAFF HAVE HAD A SHARPS INJURY DUE TO THE GLASS BREAKING THROUGH THE PLASTIC. ALSO BELOW PLEASE SEE THE INITIAL COMMUNICATION SENT TO ME VIA THE PRODUCT MANAGER. CONTACT INFO OMITTED. BUSINESS UNIT: INFECTION PREVENTION. PRODUCT LINE: CHLORAPREP. ENQUIRY: A COUPLE OF MY STAFF AND CUT THEIR FINGERS RECENTLY USING CHLORAPREP SEPP 0.67ML. THIS COULD BE A BATCH ISSUE? BATCH NUMBER 8264564.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607323 CHLORAPREP SEPP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 8264564

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other