BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS COLL II BD 7L

    MDR report key: 10463495 · Received August 27, 2020

    Report

    Report Number
    3003916417-2020-00250
    Event Type
    Malfunction
    Date Received
    August 27, 2020
    Date of Event
    August 7, 2020
    Report Date
    September 18, 2020
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    MMK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: DHR, QUALITY NOTIFICATION AND MAINTENANCE ANALYSIS WERE PERFORMED AND NO OCCURRENCES RELATED TO THE OCCURRENCE WAS OBSERVED. THE PICTURE SENT BY THE CUSTOMER WAS VERIFIED AND IT WAS POSSIBLE OBSERVE DESCARTEX BROKEN. THIS OCCURRENCE IS POTENTIALLY RELATED TO AN DAMAGE CAUSED DURING THE MATERIAL TRANSPORT OR FEEDING. H3 OTHER TEXT : SEE H.10

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS/ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: THE EVENT DESCRIPTION HAS BEEN UPDATED WITH A NEW MEDICAL DEVICE BRAND NAME. D.1. MEDICAL DEVICE BRAND NAME: SHARPS COLL II BD 7L D.2. MEDICAL DEVICE CATALOG #: 305643 D.4. MEDICAL DEVICE EXPIRATION DATE: NA D.4. MEDICAL DEVICE LOT #: 0142180 D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H.4. DEVICE MANUFACTURE DATE: 2020-05-21

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHARPS COLL II BD 7L WAS DAMAGED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE RECEIVED THE NF 555249 WHERE WE FOUND THAT THE FOLLOWING PRODUCT ARRIVED WITH MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHARPS COLL II BD 7L WAS DAMAGED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE RECEIVED THE NF 555249 WHERE WE FOUND THAT THE FOLLOWING PRODUCT ARRIVED WITH MALFUNCTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHARPS COLL II BD 13L WAS DAMAGED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE RECEIVED THE (B)(4) WHERE WE FOUND THAT THE FOLLOWING PRODUCT ARRIVED WITH MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928197 SHARPS COLL II BD 7L SHARPS CONTAINER MMK BECTON DICKINSON IND. CIRURGICAS LTDA 0142180

    Patients

    Seq Age Sex Outcome Treatment
    1 Other