BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAGSLA

    MDR report key: 11066403 · Received December 23, 2020

    Report

    Report Number
    1920898-2020-01753
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Date of Event
    October 1, 2020
    Report Date
    March 11, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. 3 PHOTOS OF (1) LOOSE 0.3ML BD INSULIN SYRINGE FROM LOT: 0020542 WERE PROVIDED. THE CUSTOMER REPORTED AT THE TIME OF UNCOVERING THE NEEDLE, IT SEPARATES FROM THE BODY OF THE SYRINGE. THE PHOTOS WERE REVIEWED, AND IT WAS OBSERVED THAT THE NEEDLE HUB/SHIELD ASSEMBLY WAS SEPARATED FROM THE BARREL; NO DAMAGE TO THE BARREL TIP WAS OBSERVED IN THE PROVIDED PHOTO. 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. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE BASED ON THE PHOTOS RECEIVED. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. CAPA:1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CLIENT STATES THAT A SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAGSLA SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "AT THE TIME OF UNCOVERING THE NEEDLE, IT SEPARATES FROM THE BODY OF THE SYRINGE", CLARIFYING THAT WE SEND ORIGINAL BOXES IN ORDERS FROM OUR WAREHOUSES, THEREFORE IT IS NOT POSSIBLE TO SHOW THIS NOVELTY IN THE PRODUCT. SYRINGE B.D 0.3 ML 31 X 6 MM X 10 UND SELF-CONTAINED INSULIN 324916".

    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 THE CLIENT STATES THAT A SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAGSLA SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: ""AT THE TIME OF UNCOVERING THE NEEDLE, IT SEPARATES FROM THE BODY OF THE SYRINGE", CLARIFYING THAT WE SEND ORIGINAL BOXES IN ORDERS FROM OUR WAREHOUSES, THEREFORE IT IS NOT POSSIBLE TO SHOW THIS NOVELTY IN THE PRODUCT. SYRINGE B.D 0.3 ML 31 X 6 MM X 10 UND SELF-CONTAINED INSULIN 324916"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1526790 SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAGSLA PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0020542

    Patients

    Seq Age Sex Outcome Treatment
    1