BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE

    MDR report key: 8090705 · Received November 20, 2018

    Report

    Report Number
    1911916-2018-00663
    Event Type
    Malfunction
    Date Received
    November 20, 2018
    Date of Event
    November 6, 2018
    Report Date
    January 25, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051060
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: IN THE PREVIOUSLY SUBMITTED MDR, BRAND NAME AND TYPE OF REPORTABLE EVENT WERE INCORRECTLY REFERENCED AS THE MEDICAL DEVICE EXPIRATION DATE AND DEVICE MANUFACTURE DATE. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED TO CORRECT THOSE REFERENCES TO SHOW THE FOLLOWING: MEDICAL DEVICE EXPIRATION DATE. DEVICE MANUFACTURE DATE.

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE LOT #: 7200896. MEDICAL DEVICE EXPIRATION DATE: 2022-08-31. DEVICE MANUFACTURE DATE: 2017-07-19.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE HAD FOREIGN MATTER ON THE NEEDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD PRECISIONGLIDE SPECIALTY USE STERILE HYPODERMIC NEEDLE HAD FOREIGN MATTER ON THE NEEDLE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. INVESTIGATION CONCLUSION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. ROOT CAUSE DESCRIPTION: NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. RATIONALE: A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE HAD FOREIGN MATTER ON THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932178 BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL UNKNOWN 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other