BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 8MM 90 BX 450 MO

    MDR report key: 11593419 · Received March 30, 2021

    Report

    Report Number
    1920898-2021-00369
    Event Type
    Malfunction
    Date Received
    March 30, 2021
    Date of Event
    March 4, 2021
    Report Date
    April 21, 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
    WI, US
    Reporter Occupation
    003

    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: 2021-04-30. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (5) LOOSE 0.3ML BD INSULIN SYRINGES. CONSUMER REPORTED FOUND 6 SYRINGES WHEN REMOVED THE NEEDLE SHIELD NEEDLE HUB ASSEMBLY REMOVED WITH IT. ALL 5 RETURNED SAMPLES WERE EXAMINED, AND IT WAS OBSERVED THAT 1 SYRINGE EXHIBITED A SEPARATED NEEDLE HUB/SHIELD ASSEMBLY; NO DAMAGE TO THE BARREL TIP WAS OBSERVED ON THIS SYRINGE. THE REMAINING 4 SYRINGES DID NOT EXHIBIT HUB SEPARATION; THE CANNULA SHIELDS FOR THESE SYRINGES WERE ABLE TO BE REMOVED PROPERLY. 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 NOTED FOR OUT OF SPEC SHIELD PULL. CAPA PR1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 6 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 HUB SEPARATES. VERBATIM: CONSUMER REPORTED FOUND 6 SYRINGES WHEN REMOVED THE NEEDLE SHIELD NEEDLE HUB ASSEMBLY REMOVED WITH IT. LOT # 0090638; CATALOG# 328291; DATE OF EVENT UNKNOWN. SAMPLE STATUS AWAITING SAMPLE FOR 4 OUT OF THE 6 FOUND."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 6 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 HUB SEPARATES. VERBATIM: CONSUMER REPORTED FOUND 6 SYRINGES WHEN REMOVED THE NEEDLE SHIELD NEEDLE HUB ASSEMBLY REMOVED WITH IT. LOT # 0090638. CATALOG# 328291. DATE OF EVENT UNKNOWN. SAMPLE STATUS AWAITING SAMPLE FOR 4 OUT OF THE 6 FOUND"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490104 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