BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿+ PEN NEEDLES 31G X 5MM (100 COUNT)

    MDR report key: 16434897 · Received February 24, 2023

    Report

    Report Number
    9616656-2023-00126
    Event Type
    Malfunction
    Date Received
    February 24, 2023
    Date of Event
    January 16, 2023
    Report Date
    March 16, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL: YES. D10: RETURNED TO MANUFACTURER ON: 10-MAR-2023. H6: INVESTIGATION SUMMARY : TWO PHOTOS OF A 31G X 5MM PEN NEEDLE CARTON WERE RETURNED FROM LOT. NO. 2242770, CAT. NO. 320594 ALONG WITH A PHOTO OF PRODUCT THAT IS NOT MANUFACTURED IN DL. AS PER INVESTIGATION, THE CURRENT LABELING ON THE 31G X 5MM PEN NEEDLE CARTON MEETS MANUFACTURING SPECIFICATIONS. CAT. NO. 320594 IS NOT DESTINED FOR LUXEMBOURG. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. BASED ON THE PHOTOS RETURNED AND THE FACT CAT. NO. 320594 IS NOT DESTINED FOR LUXEMBOURG NO ROOT CAUSE CAN BE IDENTIFIED. CAT. NO. 320586 IS DESTINED FOR THIS REGION WHICH INCLUDES THE REQUIRED LANGUAGES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MICRO-FINE¿+ PEN NEEDLES 31G X 5MM (100 COUNT) THERE WERE MISSING LANGUAGES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: CURRENTLY, WE HAVE PLACED 104 PIECES IN QUARANTINE BECAUSE THE PACKAGING IS NOT IN CONFORMITY. THERE IS NO INSCRIPTION IN FRENCH OR GERMAN.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MICRO-FINE¿+ PEN NEEDLES 31G X 5MM ((B)(4) COUNT) THERE WERE MISSING LANGUAGES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: CURRENTLY, WE HAVE PLACED (B)(4) PIECES IN QUARANTINE BECAUSE THE PACKAGING IS NOT IN CONFORMITY. THERE IS NO INSCRIPTION IN FRENCH OR GERMAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1947988 BD MICRO-FINE¿+ PEN NEEDLES 31G X 5MM (100 COUNT) HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2242770

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown