BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 0.5ML 31GA 6MM

    MDR report key: 11867639 · Received May 21, 2021

    Report

    Report Number
    1920898-2021-00585
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    April 24, 2021
    Report Date
    June 18, 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: CUSTOMER RETURNED TWO IMAGES OF A SINGLE SYRINGE WITH A POLYBAG IDENTIFYING IT AS A 0.5ML, 31 GAUGE, 6MM SYRINGE FROM LOT 0083432. THE SYRINGE HAS HAD ITS NEEDLE SHIELD AND HUB SEPARATE FROM THE BARREL. THE HUB HAS BECOME LODGED INSIDE THE SHIELD. THERE IS NO DAMAGE TO EITHER THE CONNECTOR AT THE DISTAL TIP OF THE BARREL OR ITS RESPECTIVE NEEDLE HUB. NO SIGNS OF USE AND NO OTHER DEFECTS FOUND. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0083432. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FOUR (4) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE IMAGES RECEIVED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF NEEDLE HUB SEPARATION. CAPA (B)(4) HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD SYRINGE 0.5ML 31GA 6MM THE HUB WAS SEPARATED FROM DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: "UNFORTUNATELY AGAIN, I COME TO INFORM YOU ABOUT A SYRINGE THAT CAME WITHOUT A NEEDLE".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 PRIOR TO USE WITH BD SYRINGE 0.5ML 31GA 6MM THE HUB WAS SEPARATED FROM DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "UNFORTUNATELY AGAIN, I COME TO INFORM YOU ABOUT A SYRINGE THAT CAME WITHOUT A NEEDLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763237 BD SYRINGE 0.5ML 31GA 6MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0083432

    Patients

    Seq Age Sex Outcome Treatment
    1