BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 8MM 90 BX 450 MO

    MDR report key: 11717441 · Received April 23, 2021

    Report

    Report Number
    1920898-2021-00453
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 29, 2021
    Report Date
    May 28, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903282913
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL?: YES. . D10: RETURNED TO MANUFACTURER ON: 4/30/2021. H6: INVESTIGATION: CUSTOMER RETURNED A SINGLE SYRINGE WITH 0.3ML GRADUATION MARKS WITH NO POUCH FOR IDENTIFICATION. THE SYRINGE HAS HAD ITS NEEDLE SHIELD AND HUB SEPARATED FROM THE BARREL. THE HUB HAS BECOME LODGED INSIDE THE SHIELD. THERE IS NO DAMAGE TO EITHER THE CONNECTOR AT THE DISTAL TIP OF THE BARREL OR ITS RESPECTIVE NEEDLE HUB. NO SIGNS OF USE AND NO OTHER DEFECTS FOUND. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0160991. 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. THERE WAS ONE (1) NOTIFICATION NOTED OUT OF SPEC SHIELD PULL. CAPA #1630423 WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 0.3ML 8MM 90 BX 450 MO EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FOUND 1 SYRINGE WITH NEEDLE STUCK IN THE NEEDLE SHIELD. LOT #: 0160991; CATALOG#: 328291. DATE OF EVENT: 03/29/2021.

    Additional Manufacturer Narrative · 1

    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 SYRINGE 0.3ML 8MM 90 BX 450 MO EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FOUND 1 SYRINGE WITH NEEDLE STUCK IN THE NEEDLE SHIELD LOT #: 0160991. CATALOG#: 328291. DATE OF EVENT: (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609576 SYRINGE 0.3ML 8MM 90 BX 450 MO PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328291 0160991 00382903282913

    Patients

    Seq Age Sex Outcome Treatment
    1