BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BULK SURG STRIP 1/4 X 6

    MDR report key: 4141502 · Received October 4, 2014

    Report

    Report Number
    1226348-2014-12026
    Event Type
    Injury
    Date Received
    October 4, 2014
    Date of Event
    September 29, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    HBA
    PMA / PMN Number
    PK880402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT HAS BEEN RE-OPENED AS THE DEVICE WAS RETURNED FOR INVESTIGATION. IT WAS NOTED THAT IN AN ATTEMPT TO REDUCE THESE TYPES OF COMPLAINT A NEW PACKAGING MACHINE HAS BEEN INSTALLED, WHICH REDUCES THIS RISK OF THIS TYPE OF COMPLAINT. THE MAIN ISSUE WE FOUND WAS THAT THE OPERATOR COULDN'T VERIFY THAT THE PACKAGE WAS FILLED COMPLETELY WITH THE PRODUCT BEFORE THE PACKAGE WAS SEALED. THE NEW PACKAGING MACHINE ALLOWS THE OPERATOR TO LOAD THE BAG WHILE THE BAG IS BEING SEALED AND THE OPERATOR CAN CHECK THE PACKAGE TO MAKE SURE THE BAG HAS ALL THE APPROPRIATE COMPONENTS IN IT. TRAINING WAS CONDUCTED WITH THE OPERATORS THAT PRODUCED THIS LOT NUMBER TO MAKE THEM AWARE OF THE ISSUE. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS CONTACTED REGARDING PRODUCT RETURNED; HOWEVER, PRODUCT WAS NOT RETURNED FOR EVALUATION. AS SUCH IT IS NOT POSSIBLE TO EVALUATE THE PRODUCT AND DETERMINE THE ROOT CAUSE OF THIS COMPLAINT. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PRODUCT CODE AND LOT NUMBER. WE WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR COMPLAINTS FOR THIS PRODUCT CODE. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THAT THIS LOT MET SPECIFICATION DURING MANUFACTURING PROCESSES. AT THIS TIME THIS COMPLAINT IS CONSIDERED TO BE CLOSED, SHOULD THE PRODUCT BE RETURNED AT A LATER DATE THIS COMPLAINT WILL BE RE-OPENED AND AN INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED: ONE PACKAGE OF THE SPONGE NEURO INSIDE THE NEURO CRANIOTOMY PACK ONLY CONTAINED 9 SPONGES INSTEAD OF 10. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621095 BULK SURG STRIP 1/4 X 6 COTTONOID PADDIE HBA CODMAN & SHURTLEFF, INC. 518329

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention