BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE

    MDR report key: 7684471 · Received July 12, 2018

    Report

    Report Number
    9614033-2018-00039
    Event Type
    Malfunction
    Date Received
    July 12, 2018
    Date of Event
    June 19, 2018
    Report Date
    August 16, 2018
    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

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF 3/10CC SYRINGES FROM LOT # 7240696. CUSTOMER STATES THAT ONE SYRINGE IS WITHOUT THE GRADUATION PRINTED. THE ATTACHED PHOTOS WERE EXAMINED AND EXHIBITED ONE SYRINGE WITH NO SCALE MARKINGS PRINTED ON THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7240696 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS [200727627, 200727438, 200727290] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION [200727290] NOTED FOR MISSING PRINT. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. INVESTIGATION CONCLUSION: POSSIBLE ROOT CAUSES FOR MISSING SCALE MARKINGS INCLUDE: DAMAGE TO THE PAD. PRINT DRUM NOT TOUCHING THE PAD FOR INK TRANSFER. PAD HEAT SET INCORRECTLY.

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURER: NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD ULTRA-FINE¿ INSULIN SYRINGE WAS "WITHOUT THE GRADUATION PRINTED." NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD ULTRA-FINE INSULIN SYRINGE WAS "WITHOUT THE GRADUATION PRINTED." NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD ULTRA-FINE¿ INSULIN SYRINGE WAS "WITHOUT THE GRADUATION PRINTED." NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526245 BD ULTRA-FINE¿ INSULIN SYRINGE INSULIN SYRINGE FMF BECTON DICKINSON DE MEXICO 7240696

    Patients

    Seq Age Sex Outcome Treatment
    1 Other