BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAGSLA

    MDR report key: 10932568 · Received December 2, 2020

    Report

    Report Number
    1920898-2020-01655
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Date of Event
    November 6, 2020
    Report Date
    February 12, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0020542. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0020542. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF RISK MANAGEMENT 150RMN-0001-16 REVISION 14 INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (SYRINGE, SHIELD DOES NOT DETACH AS INTENDED) WAS CAPTURED AND ADDRESSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAGSLA SEPARATED FROM THE HUB AND LEAKED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE CUSTOMER INFORMS THAT HE IS UNABLE TO REMOVE THE NEEDLE COVER, WHEN FORCE FORCES THE NEEDLE OUT WITH THE COVER. CUSTOMER ALSO REPORTED THAT HE TRIED TO PUT THE NEEDLE BACK INTO THE SYRINGE BUT LEAKED THE MEDICINE WHEN APPLYING IT."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). 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 31GA 6MM HALFUNIT 10BAGSLA SEPARATED FROM THE HUB AND LEAKED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE CUSTOMER INFORMS THAT HE IS UNABLE TO REMOVE THE NEEDLE COVER, WHEN FORCE FORCES THE NEEDLE OUT WITH THE COVER. CUSTOMER ALSO REPORTED THAT HE TRIED TO PUT THE NEEDLE BACK INTO THE SYRINGE BUT LEAKED THE MEDICINE WHEN APPLYING IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400124 SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAGSLA PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0020542

    Patients

    Seq Age Sex Outcome Treatment
    1