BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD NEEDLE

    MDR report key: 9071078 · Received September 16, 2019

    Report

    Report Number
    2243072-2019-02030
    Event Type
    Malfunction
    Date Received
    September 16, 2019
    Date of Event
    August 4, 2019
    Report Date
    October 7, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, SO WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD NEEDLE EXPERIENCED A BROKEN NEEDLE AND AN INABILITY TO DELIVER INSULIN/MEDIATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. UNKNOWN; BATCH NO. UNKNOWN (PROVIDED 190430). 1. DESCRIPTION OF ISSUE: CUSTOMER REPORTS NEEDLE BROKE WHILE TRYING TO FILL CARTRIDGE WITH INSULIN. 2. NUMBER OF OCCURRENCES: 1. 3. DID THE CUSTOMER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? YES. 4. ITEM NUMBER: UNAVAILABLE. 5. PRODUCT LOT NUMBER: UNKNOWN. 6. FOR BD PRODUCT ONLY, ARE SAMPLES AVAILABLE FOR INVESTIGATION? NO. 7. DID ISSUE CAUSE ANY INJURY? IF YES, WHAT TYPE OF INJURY? NO. 8. MEDICAL INTERVENTION NEEDED? IF YES, WHO WAS THE 3RD PARTY AND WHAT WAS THE ASSISTANCE/TREATMENT? N/A. 9. RESOLUTION: CUSTOMER WAS ABLE TO COMPLETE LOAD WITH A NEW NEEDLE AND SYRINGE AND WERE ABLE TO RESUME INSULIN DELIVERY SUCCESSFULLY. 10. NOTE: PRODUCT CATEGORY = NEEDLE/SYRINGE ISSUE

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD NEEDLE EXPERIENCED A BROKEN NEEDLE AND AN INABILITY TO DELIVER INSULIN/MEDIATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. UNKNOWN BATCH NO. UNKNOWN (PROVIDED 190430). DESCRIPTION OF ISSUE: CUSTOMER REPORTS NEEDLE BROKE WHILE TRYING TO FILL CARTRIDGE WITH INSULIN. NUMBER OF OCCURRENCES: 1. DID THE CUSTOMER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? YES. ITEM NUMBER: UNAVAILABLE. PRODUCT LOT NUMBER: UNKNOWN. FOR BD PRODUCT ONLY, ARE SAMPLES AVAILABLE FOR INVESTIGATION? NO. DID ISSUE CAUSE ANY INJURY? IF YES, WHAT TYPE OF INJURY? NO. MEDICAL INTERVENTION NEEDED? IF YES, WHO WAS THE 3RD PARTY AND WHAT WAS THE ASSISTANCE/TREATMENT? N/A. RESOLUTION: CUSTOMER WAS ABLE TO COMPLETE LOAD WITH A NEW NEEDLE AND SYRINGE AND WERE ABLE TO RESUME INSULIN DELIVERY SUCCESSFULLY. NOTE: PRODUCT CATEGORY = NEEDLE/SYRINGE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868091 UNSPECIFIED BD NEEDLE NEEDLE FMI BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other