BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYRINGE 1ML 31GA 6MM 10 BAG 500 SLA

    MDR report key: 11203977 · Received January 20, 2021

    Report

    Report Number
    1920898-2021-00091
    Event Type
    Injury
    Date Received
    January 20, 2021
    Date of Event
    December 24, 2020
    Report Date
    February 4, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO CORRECTED INFORMATION: H1: TYPE OF REPORTABLE EVENTS: SERIOUS INJURY. H6: INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. NINE PHOTOS OF 1ML BD INSULIN SYRINGES FROM LOT# 9091596 WERE PROVIDED. THE CUSTOMER REPORTED THAT THE NEEDLE FRAGMENT REMAINED INSERTED INTO THE SKIN AFTER THE NEEDLE WAS REMOVED. THE PHOTOS WERE REVIEWED, AND IT WAS OBSERVED THAT 1 SYRINGE EXHIBITED A BROKEN CANNULA. THE BROKEN CANNULA COULD HAVE CAUSED HARM TO THE USER. IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE FOR THE ISSUE BASED ON THE PHOTOS ALONE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9091596. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE BASED ON THE PHOTOS RECEIVED (CANNULA BROKEN). ROOT CAUSE CANNOT BE DETERMINED BASED ON THE PHOTOS PROVIDED ALONE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 1ML 31GA 6MM 10 BAG 500 SLA NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE A 4-YEAR-OLD SON WHO HAS BEEN USING GROWTH HORMONE (SOMATROPIN) FOR ABOUT 2 AND A HALF YEARS. I HAVE ALWAYS USED BD SYRINGES AND HAD NEVER HAD A PROBLEM. ON (B)(6) MY WIFE WENT TO APPLY THE HORMONE AND NEEDLE FRACTURED. I WOULD LIKE SOME INFORMATION ABOUT THIS EVENT, SINCE IT WAS THE FIRST TIME THIS HAPPENED. WE WERE VERY CONCERNED ABOUT WHAT HAPPENED."

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: UNKNOWN. THE PATIENT¿S AGE WAS USED TO DETERMINE A PLACEHOLDER DATE FOR THIS FIELD. 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 SYRINGE 1ML 31GA 6MM 10 BAG 500 SLA NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE A(B)(6) YEAR-OLD SON WHO HAS BEEN USING GROWTH HORMONE (SOMATROPIN) FOR ABOUT 2 AND A HALF YEARS. I HAVE ALWAYS USED BD SYRINGES AND HAD NEVER HAD A PROBLEM. ON 12/24 MY WIFE WENT TO APPLY THE HORMONE AND NEEDLE FRACTURED. I WOULD LIKE SOME INFORMATION ABOUT THIS EVENT, SINCE IT WAS THE FIRST TIME THIS HAPPENED. WE WERE VERY CONCERNED ABOUT WHAT HAPPENED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100049 SYRINGE 1ML 31GA 6MM 10 BAG 500 SLA SYRINGE FMF BD MEDICAL - DIABETES CARE 9091596

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR