BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE

    MDR report key: 13157642 · Received January 4, 2022

    Report

    Report Number
    1920898-2021-01359
    Event Type
    Malfunction
    Date Received
    January 4, 2022
    Date of Event
    December 6, 2021
    Report Date
    January 13, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE : UNKNOWN. 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: D.9. DEVICE AVAILABLE FOR EVAL?: YES D.9. RETURNED TO MANUFACTURER ON: 1/6/2022 H.6. INVESTIGATION: CUSTOMER RETURNED (1) 3/10CC, 8MM, 31G SYRINGE IN AN OPEN POLY BAG FROM LOT # 0160001. CUSTOMER STATES THAT THE NEEDLE WIILL NOT DRAW, PLUNGER ROD APPEARED TO BE BLOCKED AND BOUNCED BACK WHILE DRAWING. THE RETURNED SYRINGE WAS TESTED AND WAS ABLE TO DRAW AND EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0160001. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD INSULIN SYRINGE WITH THE BD ULTRA FINE¿NEEDLE WAS DIFFICULT TO PRIME AND INJECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER :   THE CONSUMER REPORTED THAT THE NEEDLE WILL NOT DRAW AND STATED THAT THE PLUNGER ROD APPEARED TO BE BLOCKED AND BOUNCED BACK WHILE TRYING TO DRAW. DATE OF EVENT : UNKNOWN. SAMPLES : AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD INSULIN SYRINGE WITH THE BD ULTRA FINE¿NEEDLE WAS DIFFICULT TO PRIME AND INJECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER :   THE CONSUMER REPORTED THAT THE NEEDLE WILL NOT DRAW AND STATED THAT THE PLUNGER ROD APPEARED TO BE BLOCKED AND BOUNCED BACK WHILE TRYING TO DRAW. DATE OF EVENT : UNKNOWN SAMPLES : AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1192974 BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0160001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown