BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 9372667 · Received November 25, 2019

    Report

    Report Number
    3003916417-2019-00591
    Event Type
    Malfunction
    Date Received
    November 25, 2019
    Date of Event
    November 8, 2019
    Report Date
    November 13, 2019
    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 · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9030851, MEDICAL DEVICE EXPIRATION DATE: 2024-01-31, DEVICE MANUFACTURE DATE: 2019-01-31. MEDICAL DEVICE LOT #: 9112781, MEDICAL DEVICE EXPIRATION DATE: 2024-04-30, DEVICE MANUFACTURE DATE: 2019-04-25. " INITIAL REPORTER ADDITIONAL PHONE #: (B)(6). INVESTIGATION SUMMARY: NO SAMPLES OR PHOTOS WERE RECEIVED; THEREFORE, SAMPLE ANALYSIS COULD NOT BE PERFORMED AND THE CONDITION REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. INVESTIGATION CONCLUSION: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF NEEDLE BENT FOR LOT #9112781 ITEM #990193. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 18TH RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF NEEDLE CLOGGED / BLOCKED FOR LOT #9112781 ITEM #990193. RELATED COMPLAINTS: (B)(4). A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 14TH RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF NEEDLE CLOGGED / BLOCKED FOR LOT #9030851 ITEM #990193. RELATED COMPLAINTS: (B)(4). A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE COLUMBUS BATCHES WHICH WERE USED AS COMPONENTS IN THE CURITIBA BATCHES ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEWS DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. ROOT CAUSE DESCRIPTION: 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. RATIONALE: BASED ON THE INVESTIGATION CONCLUSION AND WITHOUT A SAMPLE TO ANALYZE, THE CONDITION REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE PROPOSED IN THE SCOPE OF THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE IS BLOCKED WITH A BD PRECISIONGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: NEEDLE CLOGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168200 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON IND. CIRURGICAS LTDA SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other