BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 0.3ML 30GA 8MM

    MDR report key: 12468431 · Received September 14, 2021

    Report

    Report Number
    1920898-2021-00985
    Event Type
    Malfunction
    Date Received
    September 14, 2021
    Date of Event
    August 17, 2021
    Report Date
    September 17, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED SEVERAL IMAGES OF TWO 0.3ML, 30 GAUGE, 8MM SYRINGES FROM LOT 0286309. THE SYRINGES HAD THEIR NEEDLE SHIELDS AND HUBS SEPARATE FROM THE BARRELS. THE HUBS HAVE BECOME LODGED INSIDE THE SHIELDS. THERE IS NO DAMAGE TO EITHER THE CONNECTORS AT THE DISTAL TIPS OF THE BARRELS OR THEIR RESPECTIVE NEEDLE HUBS. NO SIGNS OF USE AND NO OTHER DEFECTS FOUND. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0286309 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE IMAGES RECEIVED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF NEEDLE HUB SEPARATION. CAPA#1630423 WAS INITIATED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD SYRINGE 0.3ML 30GA 8MM HUBS SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER REPORTED THAT THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE BARREL.

    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 2 BD SYRINGE 0.3ML 30GA 8MM HUBS SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER REPORTED THAT THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1367131 BD SYRINGE 0.3ML 30GA 8MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0286309

    Patients

    Seq Age Sex Outcome Treatment
    1