BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BLUNT FILL NEEDLE

    MDR report key: 9316314 · Received November 13, 2019

    Report

    Report Number
    3002682307-2019-00607
    Event Type
    Malfunction
    Date Received
    November 13, 2019
    Date of Event
    October 29, 2019
    Report Date
    December 9, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED A PHOTO FOR CATALOG 303129 LOTS 190923, 190904, 190709, AND 190706 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF THE PHOTO SHOWS A BROKEN HUB AT THE LEVEL OF THE PRESFIT (PLASTIC PART). AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. BASED ON THE AVAILABLE INFORMATION AND THE BATCH HISTORY REVIEW, NO ROOT CAUSE CAN BE DETERMINED AS IT RELATES TO THE NEEDLE MANUFACTURING PROCESS. IF A SAMPLE FOR THIS RECORD BECOMES AVAILABLE, THE RECORD WILL BE RE-OPENED AND RE-INVESTIGATED APPROPRIATELY. AS THIS IS THE FIRST TIME THIS LOT HAS BEEN REPORTED FOR THIS DEFECT AND THE DEVICE HISTORY REVIEW SHOWS NO INDICATION OF THE DEFECT, NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BLUNT FILL NEEDLE BROKE DURING USE. THERE WERE 4 POTENTIAL LOTS AND IT WAS UNCLEAR WHICH ONE WAS INVOLVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING PUNCTURING A BOTTLE OF MORPHINE, THE NEEDLE BROKE OFF AND FLEW 2.5 METERS AWAY.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 190923. MEDICAL DEVICE EXPIRATION DATE: 2024-08-31. DEVICE MANUFACTURE DATE: 2019-09-11. MEDICAL DEVICE LOT #: 190904. MEDICAL DEVICE EXPIRATION DATE: 2024-08-31. DEVICE MANUFACTURE DATE: 2019-08-29. MEDICAL DEVICE LOT #: 190709. MEDICAL DEVICE EXPIRATION DATE: 2024-06-30. DEVICE MANUFACTURE DATE: 2019-07-09. MEDICAL DEVICE LOT #: 190706. MEDICAL DEVICE EXPIRATION DATE: 2024-06-30. DEVICE MANUFACTURE DATE: 2019-07-09. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD BLUNT FILL NEEDLE BROKE DURING USE. THERE WERE 4 POTENTIAL LOTS AND IT WAS UNCLEAR WHICH ONE WAS INVOLVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING PUNCTURING A BOTTLE OF MORPHINE, THE NEEDLE BROKE OFF AND FLEW 2.5 METERS AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108257 BD BLUNT FILL NEEDLE NEEDLE FMI BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other