BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 8507013 · Received April 11, 2019

    Report

    Report Number
    1911916-2019-00371
    Event Type
    Malfunction
    Date Received
    April 11, 2019
    Date of Event
    March 11, 2019
    Report Date
    April 24, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051114
    PMA / PMN Number
    K021475
    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

    INVESTIGATION: ONE (1) SAMPLE WAS PROVIDED BY THE CUSTOMER FOR ANALYSIS. ONE (1) END OF THE BLISTER PACK HAS NOT BEEN SEALED AND THERE IS BLACK MATERIAL ON THE END OF THE NEEDLE HUB. AN UNSEALED PACKAGE CAN RESULT FROM AN OPERATOR NOT CLEARING THE ROW OF UNSEALED PACKAGES WHEN THE PACKING MACHINE IS STOPPED DUE TO LOAD CELL FAULT. FOREIGN MATTER (FM) COULD RESULT FROM THE MANUFACTURING PROCESS AND WAS ALLOWED INSIDE THE UNSEALED PACKAGE. A DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SEAL INTEGRITY IS COMPROMISED AS WELL AS FOREIGN MATTER WITH A BD PRECISIONGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED CUSTOMER RECEIVED ONE UNSEALED NEEDLE WITH BLACK COLORING AROUND THE HEAD/SCREW THREAD. 1. DESCRIPTION OF ISSUE: CONTACT REPORTED CUSTOMER RECEIVED ONE UNSEALED NEEDLE WITH BLACK COLORING AROUND THE HEAD/SCREW THREAD. 2. DID THE CUSTOMER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? O NO. PROCEED TO STEP 3. 3. NUMBER OF OCCURRENCES: 1 4. ITEM NUMBER ¿ 26 G, 1/2¿ NEEDLE ¿ 305111 5. PRODUCT LOT NUMBER: M8172842 (NEEDLE), M182892 (BOX) 6. ARE SAMPLES AVAILABLE FOR INVESTIGATION?O YES. DOES CUSTOMER AUTHORIZE BD TO CONTACT CUSTOMER TO OBTAIN SAMPLE(S)? ____YES. 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? NO.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE EVALUATED BY MFR: 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 SEAL INTEGRITY IS COMPROMISED AS WELL AS FOREIGN MATTER WITH A BD PRECISIONGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED CUSTOMER RECEIVED ONE UNSEALED NEEDLE WITH BLACK COLORING AROUND THE HEAD/SCREW THREAD. DESCRIPTION OF ISSUE: CONTACT REPORTED CUSTOMER RECEIVED ONE UNSEALED NEEDLE WITH BLACK COLORING AROUND THE HEAD/SCREW THREAD. DID THE CUSTOMER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? NO. PROCEED TO STEP 3. NUMBER OF OCCURRENCES: 1. ITEM NUMBER: 26 G, 1/2¿ NEEDLE ¿ 305111. PRODUCT LOT NUMBER: M8172842 (NEEDLE), M182892 (BOX). ARE SAMPLES AVAILABLE FOR INVESTIGATION?O YES. DOES CUSTOMER AUTHORIZE BD TO CONTACT CUSTOMER TO OBTAIN SAMPLE(S)? YES. 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? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298429 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL UNKNOWN 30382903051114

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other