BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE

    MDR report key: 11478706 · Received March 14, 2021

    Report

    Report Number
    1920898-2021-00290
    Event Type
    Malfunction
    Date Received
    March 14, 2021
    Date of Event
    February 15, 2021
    Report Date
    April 23, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: (B)(6) 2021. H.6. INVESTIGATION: CUSTOMER RETURNED (1) 1/2CC, 6MM, 31G SYRINGE IN AN OPEN POLY BAG FROM LOT # 9140639. CUSTOMER STATES THAT A SYRINGE CAME WITHOUT A NEEDLE. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9140639. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. CAPA#(B)(4) WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CAREGIVER OF A DOG GOT IN TOUCH WITH US INFORMING THAT SHE HAS BEEN APPLYING INSULIN TO THE ANIMAL SINCE JULY LAST YEAR AND ALWAYS USES THE BD ULTRA-FINE 6MM SYRINGE PACKS CAPACITY 50UI (BATCH 9140639C; FB (B)(6) 2019; VAL 2024/06) , IN THE LAST PACKAGE PURCHASED A SYRINGE CAME WITHOUT A NEEDLE, WE ASKED IF THE NEEDLE GOT STUCK IN THE ORANGE PROTECTIVE COVER AND THE CUSTOMER SAID NO.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 THE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CAREGIVER OF A DOG GOT IN TOUCH WITH US INFORMING THAT SHE HAS BEEN APPLYING INSULIN TO THE ANIMAL SINCE JULY LAST YEAR AND ALWAYS USES THE BD ULTRA-FINE 6MM SYRINGE PACKS CAPACITY 50UI (BATCH 9140639C; FB 07/2019; VAL 2024/06), IN THE LAST PACKAGE PURCHASED A SYRINGE CAME WITHOUT A NEEDLE, WE ASKED IF THE NEEDLE GOT STUCK IN THE ORANGE PROTECTIVE COVER AND THE CUSTOMER SAID NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375700 BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 9140639

    Patients

    Seq Age Sex Outcome Treatment
    1