BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 9077039 · Received September 17, 2019

    Report

    Report Number
    1911916-2019-00971
    Event Type
    Malfunction
    Date Received
    September 17, 2019
    Date of Event
    August 29, 2019
    Report Date
    September 24, 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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE SAMPLE WAS PROVIDED BY THE CUSTOMER FOR INVESTIGATION. THE RETURNED SAMPLE WAS EXAMINED USING UNAIDED VISION. THE NEEDLE SHIELD WAS REMOVED AND IT WAS OBSERVED THAT THERE IS A SECOND NEEDLE ADHERED TO THE OUTSIDE OF THE NEEDLE HUB WITH EPOXY. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCH ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEW DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. A MIS-ASSEMBLY AT THE CANNULATION OPERATION CAN CAUSE DOUBLE CANNULA. A NEEDLE MISSES THE HUB AND FALLS ON TO THE ADJACENT NEEDLE ON THE RACK. IF THE OPERATOR DOES NOT SEE IT, THE EPOXY CURES, AND THE SECOND CANNULA STICKS TO THE ASSEMBLED NEEDLE. THE DVT CAMERA THAT INSPECTS FOR EPOXY MAY CATCH THIS DEFECT IF THE DEFECT IS ON THE SIDE FACING THE CAMERA. IT IS ESSENTIALLY THE RESPONSIBILITY OF THE ASSEMBLY ASSOCIATE TO MONITOR FOR THESE DEFECTS, CORRECT THE ISSUE, AND REMOVE THE AFFECTED NEEDLES. BD ACKNOWLEDGES THAT THE PHOTO PROVIDED BY THE CUSTOMER HAD TWO CANNULA ATTACHED TO THE NEEDLE HUB. AS THIS IS CONSIDERED A RARE OCCURRENCE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE PROPOSED IN THE SCOPE OF THIS COMPLAINT. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    MATERIAL NO.: 305106; BATCH/LOT: 8090554. IT WAS REPORTED THAT DURING USE OF THE BD PRECISIONGLIDE¿ NEEDLE "THE PHYSICIAN NOTICED THE 30 GAUGE NEEDLE HAD TWO NEEDLE TIPS LIKE THE NEEDLE WAS SPLIT PRIOR TO ADMINISTRATION." THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PHYSICIAN NOTICED THE 30 GAUGE NEEDLE HAD "TWO NEEDLE TIPS LIKE THE NEEDLE WAS SPLIT" PRIOR TO ADMINISTRATION. THE REPORTER DENIED ANY ADVERSE EVENTS OR MISSED DOSES DUE TO THIS EVENT.

    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 AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO.: 305106. BATCH/LOT: 8090554. IT WAS REPORTED THAT DURING USE OF THE BD PRECISIONGLIDE¿ NEEDLE "THE PHYSICIAN NOTICED THE 30 GAUGE NEEDLE HAD TWO NEEDLE TIPS LIKE THE NEEDLE WAS SPLIT PRIOR TO ADMINISTRATION." THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PHYSICIAN NOTICED THE 30 GAUGE NEEDLE HAD "TWO NEEDLE TIPS LIKE THE NEEDLE WAS SPLIT" PRIOR TO ADMINISTRATION. THE REPORTER DENIED ANY ADVERSE EVENTS OR MISSED DOSES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872792 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 8090554 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other