BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX SPINAL SINGLE SHOT TRAYS

    MDR report key: 11315808 · Received February 11, 2021

    Report

    Report Number
    3012307300-2021-01175
    Event Type
    Malfunction
    Date Received
    February 11, 2021
    Report Date
    April 20, 2021
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE INVESTIGATION NO PRODUCT SAMPLE HAS BEEN PROVIDED. REVIEW OF DEVICE HISTORY RECORDS AND INCOMING RECORDS FOUND NO DISCREPANCIES OR ANOMALIES RELEVANT TO THE COMPLAINT. ASSAY TESTING, PERFORMED BY THE SUPPLIER PRIOR TO RELEASE OF BUPIVACAINE LOT # 04-072-EV WAS WITHIN SPECIFICATION. REVIEW OF THE STERILIZATION CERTIFICATE FOR THE TRAY LOT NUMBER 4052153 (PO# (B)(4) REVEALED THAT THE PRODUCT WAS PROCESSED ACCORDING TO VALIDATED SPECIFICATION REQUIREMENTS AND PARAMETERS. SMITH MEDICAL PERIODICALLY MONITORS SUPPLIED DRUG COMPONENTS STABILITY POST ETHYLENE OXIDE STERILIZATION THROUGHOUT THEIR EXPIRY. OUR RECORDS SHOW THAT THE SUPPLIED DRUG COMPONENTS CONTINUE TO MEET POTENCY SPECIFICATIONS. COMPLAINT INFORMATION REVIEW FOUND NO TRENDS RELEVANT TO THE DRUG LOT NUMBER, REPORTED IN THIS COMPLAINT. THE ANESTHETICS ARE SUPPLIED ITEMS AND THE COMPLAINT NOTIFICATION WAS FORWARDED TO THE SUPPLIER. BASED ON AVAILABLE INFORMATION AND EVIDENCES NO PRODUCT QUALITY PROBLEM COULD BE CONFIRMED. POSSIBLE CAUSES OF LACK OF EFFECT MAY BE ADMINISTRATION TECHNIQUE OR PATIENT ANATOMICAL VARIATIONS, INCLUDING PATHOLOGICAL OR PSYCHOLOGICAL FACTORS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BUPIVACANE IN THE TRAY WAS WEAK. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213086 PORTEX SPINAL SINGLE SHOT TRAYS ANESTHESIA CONDUCTION KIT CAZ 4052153

    Patients

    Seq Age Sex Outcome Treatment
    1