BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL TRAY (SDD) W/DRUGS

    MDR report key: 15328775 · Received August 31, 2022

    Report

    Report Number
    3012307300-2022-17065
    Event Type
    Malfunction
    Date Received
    August 31, 2022
    Date of Event
    August 21, 2020
    Report Date
    August 31, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ASSAY TESTING, PERFORMED BY THE SUPPLIER PRIOR TO RELEASE OF BUPIVACAINE WAS WITHIN SPECIFICATION. REVIEW OF THE STERILIZATION CERTIFICATE FOR THE TRAY REVEALED THAT THE PRODUCT WAS PROCESSED ACCORDING TO VALIDATED SPECIFICATION REQUIREMENTS AND PARAMETERS. SUPPLIED DRUG COMPONENTS STABILITY POST ETHYLENE OXIDE STERILIZATION ARE PERIODICALLY MONITORED 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. REVIEW OF DEVICE HISTORY RECORDS AND INCOMING RECORDS FOUND NO DISCREPANCIES OR ANOMALIES RELEVANT TO THE COMPLAINT. CATALOG AND UDI UNKNOWN, 510K UNKNOWN. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BUPIVACAINE IN THE TRAYS ARE NOT WORKING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2067780 SPINAL TRAY (SDD) W/DRUGS PAIN MANAGEMENT/PORTEX SPINAL CUSTOM SINGLE SHOT CAZ SMITHS MEDICAL ASD, INC. 3988193

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown