BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK INSULIN SYRINGE

    MDR report key: 9310173 · Received November 12, 2019

    Report

    Report Number
    9614033-2019-00273
    Event Type
    Malfunction
    Date Received
    November 12, 2019
    Date of Event
    October 28, 2019
    Report Date
    April 17, 2020
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A PHOTOGRAPH WAS RETURNED FOR THIS INVESTIGATION. HOWEVER, THE CUSTOMER INDICATED THAT THIS IS ONLY AN EXAMPLE SHOWING THE INFORMATION ON THE LABEL AS WAS EXPECTED, IT DOES NOT REPRESENT THE ACTUAL SHELF CARTON AND LABEL INVOLVED IN THIS COMPLAINT REPORT. A DHR WAS PERFORMED BY THE SITE FOR LOT 9071962 AND THERE WERE NO QUALITY NOTIFICATIONS THAT COULD BE ATTRIBUTED TO THIS DEFECT. THE LOT WAS INSPECTED, APPROVED AND SUBSEQUENTLY RELEASED ACCORDING TO THE ESTABLISHED QUALITY CRITERIA. THE MANUFACTURING SITE FURTHER INDICATED THAT DURING THE ¿VERIFICATION OF THE PRINTED MATERIALS CARRIED OUT THROUGH THE REGISTER (B)(4) REV.09, NO BLANK FIELDS WERE DETECTED, THAT IS, THE BATCH NUMBER, PRODUCT DESCRIPTION, CONTENT, EXPIRATION DATE AND BARCODE ARE PRESENT AND LEGIBLE, ADDITIONALLY THERE ARE NO RECORDS OF REPROCESSING FROM WHICH A RE-LABELING OF THE PRODUCT MAY HAVE ARISEN. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS OF THE PRODUCT INVOLVED WERE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ INSULIN SYRINGE WAS MISSING LABEL INFORMATION. THIS OCCURRED ON 800 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT NOT LABELED IN SECONDARY PACKAGING.

    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 BD PLASTIPAK¿ INSULIN SYRINGE WAS MISSING LABEL INFORMATION. THIS OCCURRED ON 800 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT NOT LABELED IN SECONDARY PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103283 BD PLASTIPAK INSULIN SYRINGE SYRINGE FMF BECTON DICKINSON DE MEXICO 9071962

    Patients

    Seq Age Sex Outcome Treatment
    1 Other