BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE PRECISIONGLIDE 30X1/2IN

    MDR report key: 9826372 · Received March 12, 2020

    Report

    Report Number
    3003916417-2020-00082
    Event Type
    Malfunction
    Date Received
    March 12, 2020
    Date of Event
    February 21, 2020
    Report Date
    March 23, 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: ONE SAMPLE WAS RECEIVED. IT CAME IN OPEN PACKAGING BLISTER; IT HAS THE PLASTIC SHIELD. A FUNCTIONAL TEST WAS PERFORMED CONNECTING THE NEEDLE ASSEMBLY TO A SYRINGE PREFILLED WITH DISTILLED WATER; IT WAS NOT POSSIBLE TO EXPEL THE SOLUTION. ALTHOUGH, THE SYMPTOM IS CONFIRMED. THE ROOT CAUSE IS UNDETERMINED. 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 A BD NEEDLE PRECISIONGLIDE 30X1/2IN WAS CLOGGED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE CONTACTED THE CLIENT TO BETTER VERIFY THE COMPLAINT RECEIVED THROUGH THE CS SECTOR. THE CLIENT INFORMS THAT HE USES THE PRECISION GLIDE NEEDLES 13MM X 0.30 (LOT: 9133643 FAB: 05-2019 VALIDITY: 04/2024) TO DO THE CARBOXITHERAPY TREATMENT. WHEN TRYING TO USE THE NEEDLE, THE GAS DOES NOT COME OUT, AS IF IT WERE CLOGGED. YOU PURCHASED A BOX FROM THE LOT AND THE DEVIATION OCCURRED ON 3 NEEDLES."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. INITIAL REPORTER PHONE #: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD NEEDLE PRECISIONGLIDE 30X1/2IN WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE CONTACTED THE CLIENT TO BETTER VERIFY THE COMPLAINT RECEIVED THROUGH THE CS SECTOR. THE CLIENT INFORMS THAT HE USES THE PRECISION GLIDE NEEDLES 13MM X 0.30 (LOT: 9133643 FAB: 05-2019 VALIDITY: 04/2024) TO DO THE CARBOXITHERAPY TREATMENT. WHEN TRYING TO USE THE NEEDLE, THE GAS DOES NOT COME OUT, AS IF IT WERE CLOGGED. YOU PURCHASED A BOX FROM THE LOT AND THE DEVIATION OCCURRED ON 3 NEEDLES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291058 NEEDLE PRECISIONGLIDE 30X1/2IN NEEDLE FMI BECTON DICKINSON IND. CIRURGICAS LTDA 9133643

    Patients

    Seq Age Sex Outcome Treatment
    1 Other