BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X100L PR BLUE SSL SDZ

    MDR report key: 9072379 · Received September 16, 2019

    Report

    Report Number
    3001741852-2019-00047
    Event Type
    Malfunction
    Date Received
    September 16, 2019
    Date of Event
    August 26, 2019
    Report Date
    November 5, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    MEG
    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

    INVESTIGATION SUMMARY: NO SAMPLE WERE RETURNED, BUT PHOTOGRAPHS OF THE ISSUE WERE PROVIDED FOR ANALYSIS. BDM-PS PERFORMED A GOODS IN DOCUMENTATION REVIEW. THE BATCHES INVOLVED IN THIS COMPLAINT MEET ALL ACCEPTABLE QUALITY LEVELS, WERE MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. 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 DGL0001017. 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. 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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: MEDICAL DEVICE CATALOG #: 47516602. MEDICAL DEVICE EXPIRATION DATE: 2024-02-13. MEDICAL DEVICE LOT #: 1825967. DEVICE MANUFACTURE DATE: 2019-03-06.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE CATALOG #: 47516602; LOT #: 1825967; EXPIRATION DATE: 2024-02-13; MANUFACTURE DATE: 2019-03-06. MEDICAL DEVICE CATALOG #: 47447602; LOT #: 1843601; EXPIRATION DATE: 2024-04-03; MANUFACTURE DATE: 2019-05-02. 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 BLUE SSL SDZ HAD INCORRECT LABEL INFORMATION. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NUMBER ON THE SUPPLIER LABEL IS WRONG (LOCATED ON SHIPPING BOX).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868000 ULTRASAFE X100L PR BLUE SSL SDZ PLUNGER ROD MEG BECTON DICKINSON 1825967

    Patients

    Seq Age Sex Outcome Treatment
    1 Other