BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE

    MDR report key: 16847870 · Received May 1, 2023

    Report

    Report Number
    1920898-2023-00272
    Event Type
    Malfunction
    Date Received
    May 1, 2023
    Date of Event
    April 7, 2023
    Report Date
    July 13, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908468039
    PMA / PMN Number
    K190054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 2276287, D4. MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2027, H4. DEVICE MANUFACTURE DATE: 03-OCT-2022. D4. MEDICAL DEVICE LOT #: 2213872, D4. MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2027, H4. DEVICE MANUFACTURE DATE: 01-AUG-2022. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, 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: 08-MAY-2023. H6: INVESTIGATION SUMMARY THE CUSTOMER RETURNED (6) 0.5ML 31G 8MM SYRINGES, REPORTING DIFFICULTY TO OPERATE (NOT DRAWING). THE SYRINGES WERE VISUALLY EXAMINED AND OBSERVED NO PHYSICAL DAMAGE. UPON VISUAL EXAMINATION, A FUNCTIONAL FLOW TEST WAS PERFORMED, AND OBSERVED PROPER FLOW OF FLUID ON ALL THE SAMPLES. BASED ON THE SAMPLE RECEIVED, EMBECTA WAS NOT ABLE TO CONFIRM THE REPORTED FAILURE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2213872 AND 2276287. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THE ROOT CAUSE CANNOT BE DETERMINED AS THE REPORTED FAILURE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE WAS UNABLE TO DRAW UP INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING 2 SYRINGES WITH 2 DIFFERENT LOT #S WILL NOT DRAW UP INSULIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE WAS UNABLE TO DRAW UP INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING 2 SYRINGES WITH 2 DIFFERENT LOT #S WILL NOT DRAW UP INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160454 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328468 SEE H10 00382908468039

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown