BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 30GA 8MM 7BAG 420CAS JP

    MDR report key: 10936625 · Received December 2, 2020

    Report

    Report Number
    1920898-2020-01661
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Date of Event
    November 9, 2020
    Report Date
    April 9, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY CUSTOMER RETURNED PHOTOS OF A 3/10CC, 8MM, 30G SYRINGE IN A POLY BAG FROM LOT # 9210505. CUSTOMER STATES THAT THERE IS NEEDLE/SHIELD SEPARATION FROM THE BARREL. THE PHOTOS WERE EXAMINED AND EXHIBITED THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 9210505 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. CAPA1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 0.3ML 30GA 8MM 7BAG 420CAS JP SEPARATED FROM NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED ABOUT NEEDLE/SHIED SEPARATION FROM THE BARREL.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 0.3ML 30GA 8MM 7BAG 420CAS JP SEPARATED FROM NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED ABOUT NEEDLE/SHIED SEPARATION FROM THE BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1402357 SYRINGE 0.3ML 30GA 8MM 7BAG 420CAS JP SYRINGE FMF BD MEDICAL - DIABETES CARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1