BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD E-Z SCRUB¿

    MDR report key: 13044195 · Received December 20, 2021

    Report

    Report Number
    1423507-2021-00055
    Event Type
    Injury
    Date Received
    December 20, 2021
    Date of Event
    December 9, 2021
    Report Date
    February 1, 2022
    Manufacturer
    CAREFUSION, INC
    Product Code
    OJU
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE MANUFACTURING BATCH RECORD AND LABORATORY RESULTS DID NOT DETERMINE ROOT CAUSE FOR THIS ISSUE. REVIEW OF PREVIOUS COMPLAINTS DID NOT IDENTIFY PREVIOUS COMPLAINTS FOR THIS LOT. OCCURRENCE RATE AND SEVERITY PER RM5983 V. 6 IDENTIFIES THIS ISSUE AS ACCEPTABLE FOR END USER. NO CAPA REQUIRED. REVIEW OF THE MANUFACTURING BATCH RECORD AND LABORATORY RESULTS DID NOT DETERMINE ROOT CAUSE FOR THIS ISSUE. REVIEW OF PREVIOUS COMPLAINTS DID NOT IDENTIFY PREVIOUS COMPLAINTS FOR THIS LOT. REVIEW OF THE FINISHED GOOD BATCH RECORD, PART NUMBER 377479, LOT 1112090, WAS PERFORMED FOR ANY DISCREPANCIES OR DEVIATIONS, INCLUDING EXCESSIVE SOAP WEIGHT, THAT WOULD CONTRIBUTE TO THIS ISSUE. NO DEVIATIONS OR DISCREPANCIES WERE IDENTIFIED DURING THE REVIEW OF THE BATCH RECORD. REVIEW BD SANDY COA DID NOT IDENTIFY ANY OUT OF SPECIFICATIONS OR DISCREPANCIES THAT WOULD CONTRIBUTE TO THIS ISSUE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    EMAIL VERBATIM: ¿HELLO, I RECEIVED THE CUSTOMER COMPLAINT BELOW FOR PRODUCT 377479 AND IT SEEMS THERE WAS AN ALLERGIC REACTION TO IT. IT IS UNCLEAR IF THE CUSTOMER USED LOT# 1112090 FOR WHICH I PROVIDED THEM THE COFA ON (B)(6) 2021 OR ANOTHER LOT#. WOULD YOU CONTACT THE CUSTOMER REGARDING THEIR QUESTION ¿CAN THIS TYPE OF PRODUCT CAUSE SUCH A LOCALIZED PLAQUE?¿ (PHOTO IN THE EMAIL BELOW). PLEASE ADVISE. THANK YOU," HELLO, RECENTLY, WE HAVE AN EMPLOYEE (B)(6) WHO INDICATED TO US THAT HE HAD A RED PATCH THAT APPEARED ON HIS SKIN (ON HIS ARM). SEE IMAGE BELOW. HE CLEANED HIS HANDS AND ARMS WITH BD CHLORHEXIDINE GLUCONATE SPONGES (PRODUCT 377479). HE DIDN'T SCRUB HIS ARM MORE INTENSELY THAN ELSEWHERE. CAN THIS TYPE OF PRODUCT CAUSE SUCH A LOCALIZED PLAQUE? THANK YOU.

    Description of Event or Problem · 0

    EMAIL VERBATIM: ¿HELLO, I RECEIVED THE CUSTOMER COMPLAINT BELOW FOR PRODUCT 377479 AND IT SEEMS THERE WAS AN ALLERGIC REACTION TO IT. IT IS UNCLEAR IF THE CUSTOMER USED LOT# 1112090 FOR WHICH I PROVIDED THEM THE COFA ON (B)(6) 2021 OR ANOTHER LOT#. WOULD YOU CONTACT THE CUSTOMER REGARDING THEIR QUESTION ¿CAN THIS TYPE OF PRODUCT CAUSE SUCH A LOCALIZED PLAQUE?¿ (PHOTO IN THE EMAIL BELOW). PLEASE ADVISE. THANK YOU," HELLO, RECENTLY, WE HAVE AN EMPLOYEE ((B)(6) HERE) WHO INDICATED TO US THAT HE HAD A RED PATCH THAT APPEARED ON HIS SKIN (ON HIS ARM). SEE IMAGE BELOW. HE CLEANED HIS HANDS AND ARMS WITH BD CHLORHEXIDINE GLUCONATE SPONGES (PRODUCT 377479). HE DIDN'T SCRUB HIS ARM MORE INTENSELY THAN ELSEWHERE. CAN THIS TYPE OF PRODUCT CAUSE SUCH A LOCALIZED PLAQUE? THANK YOU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946584 BD E-Z SCRUB¿ CHLORAHEXIDINE GLUCONATE SOLUTION OJU CAREFUSION, INC 1112090

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other