BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 9384951 · Received November 27, 2019

    Report

    Report Number
    3003916417-2019-00597
    Event Type
    Malfunction
    Date Received
    November 27, 2019
    Date of Event
    November 12, 2019
    Report Date
    January 9, 2020
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 12 SAMPLES WERE RECEIVED. THEY CAME IN AN OPEN PACKAGING BLISTER AND THEY ALL HAVE THE PLASTIC SHIELD. THEY WERE TESTED BY CONNECTING EACH OF THEM TO A SYRINGE WITH SALINE SOLUTION. THE SOLUTION DIDN¿T GO THROUGH THE NEEDLE. FAILURE MODE WAS VERIFIED. FOREIGN MATERIAL (FM) CAN BE INTRODUCED TO THE FLUID PATH DURING THE MANUFACTURING PROCESS WHICH COULD CAUSE THE NEEDLE TO BECOME CLOGGED. ALL PRODUCT IS AUTOMATICALLY CHECKED FOR CLOGGED NEEDLES DURING THE PRODUCTION PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD PRECISIONGLIDE¿ NEEDLE THERE WAS AN ISSUE WITH THE NEEDLE BEING CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: I USE BD NEEDLES A LOT (30G X ½). IT IS NORMAL ABOUT 3 PER BOX OF 100 UNITS, COME CLOGGED AND CAN NOT BE USED. IN MY LAST PURCHASE I RECEIVED NEEDLES FROM LOT 9112781 MANUFACTURED IN MAY 2019, AND SOME 15 UNITS PER BOX ARE COMING CLOGGED. BESIDES NOT BEING ABLE TO ENJOY EACH UNIT, IT HINDERS THE SERVICE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). 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 DURING USE OF THE BD PRECISIONGLIDE¿ NEEDLE THERE WAS AN ISSUE WITH THE NEEDLE BEING CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: I USE BD NEEDLES A LOT (30G X ½). IT IS NORMAL ABOUT 3 PER BOX OF 100 UNITS, COME CLOGGED AND CAN NOT BE USED. IN MY LAST PURCHASE I RECEIVED NEEDLES FROM LOT 9112781 MANUFACTURED IN MAY 2019, AND SOME 15 UNITS PER BOX ARE COMING CLOGGED. BESIDES NOT BEING ABLE TO ENJOY EACH UNIT, IT HINDERS THE SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182583 BD PRECISIONGLIDE¿ NEEDLE NEEDLE FMI BECTON DICKINSON IND. CIRURGICAS LTDA 9112781

    Patients

    Seq Age Sex Outcome Treatment
    1 Other