BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE

    MDR report key: 16890917 · Received May 8, 2023

    Report

    Report Number
    1920898-2023-00280
    Event Type
    Malfunction
    Date Received
    May 8, 2023
    Date of Event
    April 14, 2023
    Report Date
    June 29, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY CUSTOMER RETURNED TWO CLEAR ZIPLOC BAGS WITH SYRINGES AND POLYBAGS INSIDE. ONE ZIPLOC BAG WITH 41 LOOSE 0.5ML 29GA SYRINGES, ONE CLOSED POLYBAG 0.5ML 29GA (QTY 7) FROM LOT# 2220146 AND ONE EMPTY OPEN POLYBAG FROM LOT# 2220146 AND OTHER ZIPLOC BAG WITH 3 LOOSE 0.5ML 29GA SYRINGES, ONE CLOSED POLYBAG 0.5ML 29GA (QTY 7) FROM LOT# 2052388 AND EMPTY OPEN POLYBAG FROM LOT# 2052388. ALL THE SYRINGES WERE INSPECTED BY AN EXPERIENCED OPERATOR USING A SCALE MISALIGNMENT GAUGE (PLUG GAUGE) AND ALL THE SYRINGES WERE FOUND TO BE WITHIN SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORD AND LEADING 2LEAN (L2L) MAINTENANCE DISPATCH HISTORY WAS COMPLETED. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. H3 OTHER TEXT : SEE H10

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2220146, D.4. MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2027, H.4. DEVICE MANUFACTURE DATE: 08-AUG-2022. D.4. MEDICAL DEVICE LOT #: 2052388, D.4. MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2027, H.4. DEVICE MANUFACTURE DATE: 21-FEB-2022. H.3. 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 · 0

    IT WAS REPORTED THAT 47 BD ULTRA-FINE¿ INSULIN SYRINGES FROM LOT 2220146, AND 10 SYRINGES FROM LOT 2052388 HAD SLANTED/MISALIGNED SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS IS A REPORT ABOUT THE SCALE MISALIGNED. ACCORDING TO THE USER'S VERBATIM REPORT, SOME SCALES WERE FOUND PRINTED SLANTING AND STRAIGHT IN ABOUT HALF OF ONE SHELF CARTON."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 47 BD ULTRA-FINE¿ INSULIN SYRINGES FROM LOT 2220146, AND 10 SYRINGES FROM LOT 2052388 HAD SLANTED/MISALIGNED SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS IS A REPORT ABOUT THE SCALE MISALIGNED. ACCORDING TO THE USER'S VERBATIM REPORT, SOME SCALES WERE FOUND PRINTED SLANTING AND STRAIGHT IN ABOUT HALF OF ONE SHELF CARTON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1854031 BD ULTRA-FINE¿ INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown