BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD BBL¿ DRYSLIDE¿ PYR KIT

    MDR report key: 7777327 · Received August 13, 2018

    Report

    Report Number
    2647876-2018-00021
    Event Type
    Injury
    Date Received
    August 13, 2018
    Date of Event
    July 20, 2018
    Report Date
    September 7, 2018
    Manufacturer
    BD CARIBE, LTD
    Product Code
    JTO
    UDI-DI
    00382902317470
    PMA / PMN Number
    K921583/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: REQUIRED INTERVENTION. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING A BD BBL¿ DRYSLIDE¿ PYR KIT A TECHNICIAN RECEIVED A CUT FROM A GLASS AMPOULE THAT WENT THROUGH THE PACKAGING. THE PATIENT RECEIVED MEDICAL EVALUATION FOLLOWING THE INCIDENT AND WAS MONITORED FOR FEVER AND INFECTION.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: QUALITY INITIATED AN INVESTIGATION ON DRY SLIDE PYR PRODUCT. THE INVESTIGATION REQUIRED TO PERFORM FUNCTIONAL TEST (FOR AMPULE BREAKAGE-DIFFICULT TO OPEN), VISUAL INSPECTION TO RETENTION SAMPLES, INCOMING AND BATCH RECORD REVIEW. NO DISCREPANCIES OBSERVED DURING VISUAL INSPECTION. SATISFACTORY FUNCTIONAL TEST. RETENTION SAMPLES (AMPULE) WERE EASILY OPENED AND GLASS WERE NOT BROKEN DURING THE PROCESS. INCOMING AND BATCH RECORD REVIEW DID NOT SHOWED ANY EVIDENCE OF CUSTOMER CLAIM. AN INVESTIGATION WAS REQUESTED TO AMPULE SUPPLIER. THEY EVALUATED THE PRODUCT BHR, CUSTOMER COMPLAINTS FILES AND RETENTION SAMPLES. NO EVIDENCE OF BROKEN AMPULE (DURING THE OPENING PROCESS) WERE REPORTED. NO TREND OR ADDITIONAL COMPLAINT DUE TO SAME CLAIM WAS RECEIVED IN THEIR FACILITY. COMPLAINT WILL BE MONITORED FOR TREND. PRODUCT HAZARD ANALYSIS WAS EVALUATED. IT WAS OBSERVED THAT CUSTOMER CLAIM WAS NOT REFERENCED IN THE HAZARD REPORT. INVESTIGATION CONCLUSION: THE MOST PROBABLE ROOT CAUSE IDENTIFIED WAS INCORRECT HANDLING BY USER. NO EVIDENCE OF DEFECTIVE PRODUCTS WERE FOUND DURING AMPULE SUPPLIER AND BD (B)(4) INVESTIGATIONS. IN ADDITION, NO TREND HAS BEEN IDENTIFIED FOR DIFFICULT TO OPEN/BROKEN AMPULE DEFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A BD BBL¿ DRYSLIDE¿ PYR KIT A TECHNICIAN RECEIVED A CUT FROM A GLASS AMPOULE THAT WENT THROUGH THE PACKAGING. THE PATIENT RECEIVED MEDICAL EVALUATION FOLLOWING THE INCIDENT AND WAS MONITORED FOR FEVER AND INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A BD BBL¿ DRYSLIDE¿ PYR KIT A TECHNICIAN RECEIVED A CUT FROM A GLASS AMPOULE THAT WENT THROUGH THE PACKAGING. THE PATIENT RECEIVED MEDICAL EVALUATION FOLLOWING THE INCIDENT AND WAS MONITORED FOR FEVER AND INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618270 BD BBL¿ DRYSLIDE¿ PYR KIT MICROORGANISM DIFFERENTIATION AND IDENTIFICATION DEVICE JTO BD CARIBE, LTD 8071659 00382902317470

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention