BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X100L PR GREEN SSL SDZ

    MDR report key: 9083057 · Received September 18, 2019

    Report

    Report Number
    3001741852-2019-00050
    Event Type
    Malfunction
    Date Received
    September 18, 2019
    Date of Event
    August 26, 2019
    Report Date
    November 4, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE SUPPLIER MANUFACTURES, PACKAGES AND LABELS THE PRODUCT AS PER THE CURRENT TECHNICAL AGREEMENT (TA) 442.TA.021 BD SWINDON RELEASES THE PRODUCT AS PER THE ABOVE TA. THIS PRODUCT CODE ON THE TA HAS A LABEL TEMPLATE DGL0000582. THE PHOTOGRAPH PROVIDED BY THE CUSTOMER HAS THE CORRECT LABEL ATTACHED AS PER TA. HENCE THE BATCH WAS MANUFACTURED AND LABELED AS PER REQUIREMENT. THE CUSTOMER SPECIFICATION SC000124 ALSO DOES NOT DICTATE ANY SPECIFICS ON CUSTOMER LABELS RELATED TO THIS PRODUCT CODE. THE CUSTOMER MATERIAL CODE IS A PREPOPULATED ENTRY ON THE LABEL TEMPLATE WHICH POTENTIALLY INDICATES EITHER THE INCORRECT LABEL TEMPLATE WAS ASSIGNED TO THE PRODUCT OR A CHANGE REQUEST FROM THE CUSTOMER DID NOT CORRECTLY FLOW THROUGH THE WW QMS, HOWEVER IT IS BEYOND THE SCOPE OF BD SWINDON. BASED ON THE INVESTIGATION CONCLUSION, BD- SWINDON WAS NOT ABLE TO CONFIRM THE SYMPTOM PERCEIVED BY THE CUSTOMER OR CORRELATE THIS SYMPTOM WITH A POTENTIAL CAUSE LINKED TO A BD SWINDON PROCESS. BDM-PS PERFORMED A BATCH HISTORY RECORD'S REVIEW INCLUDING A REVIEW OF ALL DATA COLLECTED DURING IN PROCESS AND QUALITY INSPECTIONS. THE BATCHES INVOLVED IN THIS COMPLAINT MEET ALL ACCEPTABLE QUALITY LEVELS, WERE MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ULTRASAFE X100L PR GREEN SSL SDZ HAD INCORRECT LABEL INFORMATION. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SANDOZ MATERIAL NUMBER ON THE SUPPLIER LABEL IS WRONG (LOCATED ON SHIPPING BOX).

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ULTRASAFE X100L PR GREEN SSL SDZ HAD INCORRECT LABEL INFORMATION. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SANDOZ MATERIAL NUMBER ON THE SUPPLIER LABEL IS WRONG (LOCATED ON SHIPPING BOX).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879123 ULTRASAFE X100L PR GREEN SSL SDZ PLUNGER ROD FMF BECTON DICKINSON 1843601

    Patients

    Seq Age Sex Outcome Treatment
    1 Other