BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 8897955 · Received August 15, 2019

    Report

    Report Number
    3003916417-2019-00396
    Event Type
    Malfunction
    Date Received
    August 15, 2019
    Date of Event
    July 31, 2019
    Report Date
    September 18, 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 · 0

    INVESTIGATION SUMMARY A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE COLUMBUS BATCHES (9018599, 8324767, 8290978, 8310830, 6325652) ASSOCIATED WITH THE CURITIBA BATCHES ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEWS DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. THE BATCH NUMBERS 9018599, 8324767, 8290978, 8310830, 6325652 ARE NEEDLE HUB ASSEMBLY BATCHES WHICH WERE PRODUCED IN COLUMBUS AND THEN SHIPPED TO CURITIBA AND USED AS COMPONENTS IN THE CURITIBA BATCHES 9112781, 9133643, 9030851. AS THE COMPLAINT WAS FOR CLOGGED / BLOCKED NEEDLES THE NEEDLE ASSEMBLY MANUFACTURING BATCHES NEEDED TO BE REVIEWED. FOURTEEN (14) SAMPLES WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. THE RETURNED SAMPLES WERE VISUALLY EXAMINED AND IT WAS OBSERVED THAT THE SAMPLES WERE NOT CLOGGED AS LIGHT WAS ABLE TO PASS THROUGH THE SAMPLES. POTENTIAL ROOT CAUSE, 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. BASED ON THE INVESTIGATION CONCLUSION BD CANNOT CONFIRM THE CONDITION REPORTED BY THE CUSTOMER AS NONE OF THE RETURNED SAMPLES WERE FOUND TO BE CLOGGED. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE PROPOSED IN THE SCOPE OF THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLES CLOGGED DURING USE WHILE ADMINISTERING "ANESTHETIC LIDOCAINE HYDROCHLORIDE" OR "RADIOPHARMACEUTICAL". LOT #'S 9112781, 9133643, AND 9030851 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: "A LOT OF AREAS OF THE HOSPITAL ARE REPORTING "CLOGGING" OF THE NEEDLES DURING MEDICINE ADMINISTRATION."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9112781. MEDICAL DEVICE EXPIRATION DATE: 2024-04-30. DEVICE MANUFACTURE DATE: 2019-04-25. MEDICAL DEVICE LOT #: 9133643. MEDICAL DEVICE EXPIRATION DATE: 2024-04-30. DEVICE MANUFACTURE DATE: 2019-05-14. MEDICAL DEVICE LOT #: 9030851. MEDICAL DEVICE EXPIRATION DATE: 2024-01-31. DEVICE MANUFACTURE DATE: 2019-01-31. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLES CLOGGED DURING USE WHILE ADMINISTERING "ANESTHETIC LIDOCAINE HYDROCHLORIDE" OR "RADIOPHARMACEUTICAL". LOT #'S 9112781, 9133643, AND 9030851 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "A LOT OF AREAS OF THE HOSPITAL ARE REPORTING "CLOGGING" OF THE NEEDLES DURING MEDICINE ADMINISTRATION." MEDICINES ADMINISTERED: ANESTHETIC LIDOCAINE HYDROCHLORIDE AND RADIOPHARMACEUTICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693708 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON IND. CIRURGICAS LTDA SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other