BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ GLASPAK

    MDR report key: 8185495 · Received December 20, 2018

    Report

    Report Number
    1625685-2018-00064
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    October 24, 2018
    Report Date
    January 22, 2019
    Manufacturer
    CAREFUSION, INC
    Product Code
    CAZ
    UDI-DI
    00382904056711
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE SAMPLE WAS RECEIVED FOR EVALUATION. SAMPLE EVALUATION CONFIRMED THE REPORTED FAILURE MODE. ¿5ML GLASS PACK THAT¿S IN THE TRAY, THE SYRINGE IN THAT PACK HAS AN EXTRA GLASS TIP INSIDE THE GLASS SYRINGE.¿ A DEVICE HISTORY RECORD REVIEW OF ALL APPLICABLE MANUFACTURING RECORDS FOR LOT 0001250402 DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. INVESTIGATION CONCLUSION: THE COMPLAINT INVESTIGATION WAS ABLE TO CONFIRM THE REPORTED FAILURE MODE; HOWEVER, THE GLASS SYRINGE IS MANUFACTURED AT A SISTER FACILITY. ROOT CAUSE DESCRIPTION: A PROBABLE ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE MANNFORD MANUFACTURING FACILITY BASED ON THE INVESTIGATION RESULTS. RATIONALE: THE INVESTIGATION WAS NOT ABLE TO IDENTIFY ANY CORRECTIVE ACTIONS FOR THIS COMPLAINT. BASED ON THE REPORTED FAILURE MODE, A SUPPLIER QUALITY NOTIFICATION WAS SENT TO THE VENDOR (BD-BRAZIL) TO NOTIFY THE VENDOR OF THE REPORTED FAILURE MODE (EXTRA GLASS TIP IN SYRINGE). LIKEWISE, THE COMPLAINT WILL BE ENTERED INTO THE COMPLAINT MANAGEMENT SYSTEM AND WILL BE TRACKED & TRENDED FOR FUTURE OCCURRENCES AND REVIEWED/INVESTIGATED THROUGH THE QUALITY DATA ANALYSIS (QDA) PROCESS IF AN ADVERSE TREND IS IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD¿ GLASPAK HAD FOREIGN MATTER INSIDE THE SYRINGE.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD¿ GLASPAK HAD FOREIGN MATTER INSIDE THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026761 BD¿ GLASPAK INTRATHECAL ANAESTHESIA KIT CAZ CAREFUSION, INC 0001250402 00382904056711

    Patients

    Seq Age Sex Outcome Treatment
    1 Other