BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD E-Z SCRUB IMPREGNATED PREOPERATIVE SCRUB BRUSHES

    MDR report key: 12056728 · Received June 24, 2021

    Report

    Report Number
    1710034-2021-00527
    Event Type
    Injury
    Date Received
    June 24, 2021
    Date of Event
    May 19, 2021
    Report Date
    September 13, 2021
    Manufacturer
    BD SANDY
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF DHR DID NOT FIND ANY ATTRIBUTABLE DEFICIENCIES THAT WOULD LEAD TO THIS ISSUE. REVIEW OF EQUIPMENT MAINTENANCE RECORDS DID NOT IDENTIFY ANY ACTIVITIES THAT WOULD CONTRIBUTE TO THIS ISSUE. REVIEW OF THE BATCH RECORD SHOWS THAT PRODUCTION WAS PERFORMED AS SPECIFIED AND ALL IN-PROCESS QUALITY CHECKS MET ESTABLISHED SPECIFICATIONS, INCLUDING ATTRIBUTE CHECKS. REVIEW OF LOT HISTORY SHOW NO NON-CONFORMANCE EVENTS ISSUED FOR THIS LOT. ROOT CAUSE FOR THIS ISSUE CANNOT BE ESTABLISHED AT THIS TIME. FIRST COMPLAINT OF THIS LOT AND REVIEW OF DHR IN-PROCESS QUALITY CHECKS INDICATE THAT THIS IS A LOW OCCURRENCE WITH THIS LOT. ANY FUTURE COMPLAINTS WILL CONTINUE TO BE MONITORED FOR THIS LOT AND ASSESSED.

    Description of Event or Problem · 0

    MATERIAL NO.: 371163, BATCH NO.: 1063306. IT WAS REPORTED THAT BD E-Z SCRUB 116 CONTAINED METAL SHARD WHICH CUT STAFF MEMBER. PER CUSTOMER RESPONSE: WHAT IS THE MATERIAL AND LOT NUMBER? LOT: 1063306, REFERENCE (B)(4), EXPIR. DATE: 12/22, NDC (B)(4). WAS THERE ANY MEDICAL TREATMENT REQUIRED FOR THE CUT? NO, JUST FIRST AID. IS THE DEVICE AVAILABLE FOR INVESTIGATION? NO. WE X-RAYED IT BEFORE DISPOSAL AND THERE WERE NO ADDITIONAL FOREIGN BODIES IN THE SPONGES. THE SHARD WAS DISPOSED OF AFTER REMOVAL FROM EMPLOYEE¿S HAND. PER COMPLAINT DETAILS RECEIVED: BD E-Z SCRUBB 116 CONTAINED METAL SHARD WHICH CUT STAFF MEMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). PR (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.: 371163, BATCH NO.: 1063306. IT WAS REPORTED THAT BD E-Z SCRUB 116 CONTAINED METAL SHARD WHICH CUT STAFF MEMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954773 BD E-Z SCRUB IMPREGNATED PREOPERATIVE SCRUB BRUSHES 3% CHLOROXYLENOL (PCMX) KXG BD SANDY 1063306

    Patients

    Seq Age Sex Outcome Treatment
    1 Other