BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 8MM HALFUNIT 10BG 500

    MDR report key: 11499777 · Received March 16, 2021

    Report

    Report Number
    1920898-2021-00307
    Event Type
    Malfunction
    Date Received
    March 16, 2021
    Date of Event
    February 11, 2021
    Report Date
    March 19, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908440035
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. ONE PHOTO OF (B)(4) LOOSE 0.3ML BD INSULIN SYRINGES WAS PROVIDED. THE CUSTOMER REPORTED THAT THE PRINTING ON THE EXTERIOR OF THE SYRINGE WAS DEFECTIVE. THE PHOTO WAS EXAMINED, AND IT WAS OBSERVED THAT THE SCALE MARKINGS BETWEEN THE 0 AND 5 UNIT MARKS WERE MISSING. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0203537. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WAS ONE (1) NOTIFICATION [200902242] NOTED FOR DAMAGED TIPS CAUSING MISSING PRINT. ROOT CAUSE: TIMING WAS OFF CAUSING DAMAGED BARREL TIPS AND PRINT ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYRINGE 0.3ML 31GA 8MM HALFUNIT 10BG 500 HAD SCALE MARKING ISSUES BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE PRINTING ON THE EXTERIOR OF THE SYRINGE WAS DEFECTIVE. VERBATIM: "I'VE RECEIVED QUALITY REPORTS ON LOT #0203537 OF NDC 08290328440. IT LOOKS LIKE AN EXTERNAL SYRINGE PRINTER ISSUE FOR THE MEASUREMENTS. WOULD THERE BE ANY QUALITY CONCERN WITH PATIENT USE?"

    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 A SYRINGE 0.3ML 31GA 8MM HALFUNIT 10BG 500 HAD SCALE MARKING ISSUES BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE PRINTING ON THE EXTERIOR OF THE SYRINGE WAS DEFECTIVE. VERBATIM: I'VE RECEIVED QUALITY REPORTS ON LOT #0203537 OF NDC 08290328440. IT LOOKS LIKE AN EXTERNAL SYRINGE PRINTER ISSUE FOR THE MEASUREMENTS. WOULD THERE BE ANY QUALITY CONCERN WITH PATIENT USE?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392302 SYRINGE 0.3ML 31GA 8MM HALFUNIT 10BG 500 PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328440 0203537 00382908440035

    Patients

    Seq Age Sex Outcome Treatment
    1