BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 8MM 90 BX 450 MO

    MDR report key: 10841118 · Received November 14, 2020

    Report

    Report Number
    1920898-2020-01571
    Event Type
    Malfunction
    Date Received
    November 14, 2020
    Date of Event
    October 23, 2020
    Report Date
    December 11, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903282913
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    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: 11/18/2020. H.6. INVESTIGATION: CUSTOMER RETURNED (1) 3/10CC, 8MM, 31G SYRINGE IN AN OPEN POLY BAG FROM LOT # 0090638. CUSTOMER STATES THAT THE NEEDLE HUB SEPARATED AND STAYED INSIDE OF THE SHIELD. THE RETURNED SYRINGE WAS TESTED AND THE HUB ASSEMBLY DID NOT SEPARATE FROM THE BARREL WHEN THE SHIELD WAS REMOVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0090638 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200894508] NOTED FOR OUT OF SPEC SHIELD PULL. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 2ND RELATED COMPLAINT FOR NEEDLE HUB SEPARATES ON LOT # 0090638 H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYRINGE 0.3ML 8MM 90 BX 450 MO SEPARTED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLE HUB SEPARATED AND STAYED INSIDE OF THE SHIELD. VERBATIM: CONSUMER REPORTED THAT THE NEEDLE HUB SEPARATEDAND STAYED INSIDE OF THE SHIELD. CONSUMER DID NOT HAVE DIFFICULTY REMOVING THE SHIELD."

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYRINGE 0.3ML 8MM 90 BX 450 MO SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLE HUB SEPARATED AND STAYED INSIDE OF THE SHIELD. VERBATIM: CONSUMER REPORTED THAT THE NEEDLE HUB SEPARATED AND STAYED INSIDE OF THE SHIELD. CONSUMER DID NOT HAVE DIFFICULTY REMOVING THE SHIELD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305929 SYRINGE 0.3ML 8MM 90 BX 450 MO PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328291 0090638 00382903282913

    Patients

    Seq Age Sex Outcome Treatment
    1