BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD E-Z SCRUB

    MDR report key: 11683605 · Received April 18, 2021

    Report

    Report Number
    1710034-2021-00315
    Event Type
    Malfunction
    Date Received
    April 18, 2021
    Date of Event
    March 23, 2021
    Report Date
    July 12, 2021
    Manufacturer
    BD SANDY
    Product Code
    GEC
    UDI-DI
    00382903716036
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP E MDR: ROOT CAUSE CANNOT BE DETERMINED FROM THE MANUFACTURING INVESTIGATION. INSPECTION OF THE RETURNED SAMPLES SHOW THAT THE PRODUCT IS DIFFICULT TO OPEN. NO OTHER COMPLAINTS FROM THIS LOT HAVE BEEN LOGGED. PRODUCT IS NON-DRUG AND NO RETAIN SAMPLES ARE AVAILABLE FOR INSPECTION. POSSIBLE ROOT CAUSE FOR THIS COMPLAINT IS EXTENDED DWELL TIME OF MACHINE; HOWEVER, NOTHING WAS NOTED IN THE BATCH RECORD TO INDICATED THAT DWELL TIME IS THE CAUSE OF THIS COMPLAINT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    MATERIAL NO. 371603, BATCH NO. 0182223. IT WAS REPORTED THAT PACKAGE WAS SEALED INCORRECTLY. VERBATIM: A STAFF MEMBER CALLED ON (B)(6) 2021 FROM THIS FACILITY TO REPORT AN INCIDENT THAT [CUSTOMER] WITNESSED. THIS E-Z SCRUB PACKAGE HAD 2-3 DIFFERENT PACKAGES THAT WERE DIFFICULT TO OPEN AND SEEMED LIKE THE SIDE THEY NORMALLY OPEN WAS NOT SEALED PROPERLY. CUSTOMER HAS PRODUCT AVAILABLE FOR RETURN.

    Additional Manufacturer Narrative · 1

    NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. NO PATIENT INVOLVEMENT. UNSEALED DEVICE PACKAGING. (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    MATERIAL NO. 371603, BATCH NO. 0182223. IT WAS REPORTED THAT PACKAGE WAS SEALED INCORRECTLY. VERBATIM: A STAFF MEMBER CALLED ON 23-MAR-2021 FROM THIS FACILITY TO REPORT AN INCIDENT THAT [CUSTOMER] WITNESSED. THIS E-Z SCRUB PACKAGE HAD 2-3 DIFFERENT PACKAGES THAT WERE DIFFICULT TO OPEN AND SEEMED LIKE THE SIDE THEY NORMALLY OPEN WAS NOT SEALED PROPERLY. CUSTOMER HAS PRODUCT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580925 BD E-Z SCRUB IMPREGNATED PREOPERATIVE SCRUB BRUSHES (3% CHLOROXYLENOL (PCMX)) GEC BD SANDY 371603 0182223 00382903716036

    Patients

    Seq Age Sex Outcome Treatment
    1