BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS COLL 8QT NEST OPEN TOP NEEDL PORT

    MDR report key: 10002590 · Received April 27, 2020

    Report

    Report Number
    2243072-2020-00666
    Event Type
    Malfunction
    Date Received
    April 27, 2020
    Date of Event
    April 7, 2020
    Report Date
    June 24, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    50382903053433
    PMA / PMN Number
    K943134
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THE DHR REVIEW PROCESS WAS PERFORMED AND WAS FOUND THAT THERE WERE NOT ISSUES REPORTED, AS LID WILL NOT SHUT DURING THE MANUFACTURING PROCESS OF THE LOTS REPORTED UNDER THIS COMPLAINT. A REVIEW OF THE NCMR¿S WAS PERFORMED; THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE TEMPORARY LIDS DEFECTIVE FOR THE SAME PART NUMBER THROUGHOUT THE LAST TWELVE MONTHS. ROOT CAUSE: MOLD WORN OUT CAUSING A RETENTION FORCE IN THE MINIMUM SPECIFICATION. BASED ON THIS INVESTIGATION THIS COMPLAINT WAS NOT CONFIRMED AS FAILURE AGAINST CUSTOMER SPECIFICATION, THE TEST PERFORMED BY BDJ WAS NOT CONFIRMED AS EVALUATED IN ACCORDANCE TO CUSTOMER SPECIFICATION (THE PIECES ARE OPENING BY THEMSELVES AFTER 1HOUR) HOWEVER, AN IMPROVEMENT OPPORTUNITY WAS IDENTIFIED AS PART OF THIS INVESTIGATION SINCE THE CUSTOMER INDICATES THAT AFTER A PERIOD OF TIME THE LIDS OPEN BY THEMSELVES, EVEN THOUGH THIS ISN¿T A CHARACTERISTIC TO BE EVALUATED PER SPECIFICATION REQUIREMENTS IT CAN BE IMPROVED INCREASING THE RETENTION FORCE IN THE TEMPORARY CLOSE POSITION OF THE LID. BECAUSE OF THIS, THE MOLD INSERTS WERE REPLACED ONCE THE ROOT CAUSE WAS IDENTIFIED AND IMPROVEMENT ACTION WILL BE IMPLEMENTED TO DETECT WHEN THE RETENTION FORCE START TO DECREASE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 120 SHARPS COLL 8QT NEST OPEN TOP NEEDL PORTS EXPERIENCED A LID THAT WAS DIFFICULT TO CLOSE/WOULD NOT CLOSE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LIDS DID NOT CLOSE PROPERLY.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8196925. MEDICAL DEVICE EXPIRATION DATE: NA. DEVICE MANUFACTURE DATE: 2018-07-23. MEDICAL DEVICE LOT #: 8213918. MEDICAL DEVICE EXPIRATION DATE:NA. DEVICE MANUFACTURE DATE: 2018-08-11. MEDICAL DEVICE LOT #: 8355913. MEDICAL DEVICE EXPIRATION DATE: NA. DEVICE MANUFACTURE DATE: 2018-12-29. MEDICAL DEVICE LOT #: 9073908. MEDICAL DEVICE EXPIRATION DATE: NA. DEVICE MANUFACTURE DATE: 2019-03-24. MEDICAL DEVICE LOT #: 8149941. MEDICAL DEVICE EXPIRATION DATE: NA. DEVICE MANUFACTURE DATE: 2018-06-07. OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 120 SHARPS COLL 8QT NEST OPEN TOP NEEDL PORTS EXPERIENCED A LID THAT WAS DIFFICULT TO CLOSE/WOULD NOT CLOSE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LIDS DIDN'T CLOSE PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467275 SHARPS COLL 8QT NEST OPEN TOP NEEDL PORT HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 305343 SEE H.10 50382903053433

    Patients

    Seq Age Sex Outcome Treatment
    1 Other