BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS COLL SLIDE CLOSE 19GAL PHARM

    MDR report key: 12451037 · Received September 9, 2021

    Report

    Report Number
    2243072-2021-02277
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Date of Event
    August 13, 2021
    Report Date
    December 1, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    50382903053280
    PMA / PMN Number
    K943134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-09-08. H6: INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND INVESTIGATED BY OUR SUPPLIER. BASED ON INFORMATION PROVIDED IT WAS NOT POSSIBLE TO CONFIRM THE ROOT CAUSE LIKE A FAILURE MODE RELATED TO THE MANUFACTURING PROCESS BECAUSE THERE IS NOT ENOUGH INFORMATION LIKE METHOD USED TO HANDLE, SHIPPED PARTIAL SELLS AND CONTROLS TO STORAGE THE REMAINING PRODUCT WITHIN DISTRIBUTOR FACILITY. THE CONTROLS WERE VERIFIED WITHIN THE MANUFACTURING PROCESS AND CONFIRMED AS CAPABLE TO DETECT THE LACK OF MISSING LIDS. IF ADDITIONAL INFORMATION THAT HELPS TO FIND THE ROOT CAUSE CAN BE PROVIDED, THEN A NEW COMPLAINT RECORD WILL BE OPEN TO INITIATE A NEW INVESTIGATION PATH. POTENTIAL ROOT CAUSE: NON-CONTROLLED METHOD TO SHIP PARTIAL BOXES TO END USER (RE-PACKAGING PROCESS). NON CONTROLLED HANDLING WITHIN DISTRIBUTOR FACILITIES. ACCORDING TO THE DHR REVIEW PROCESS, THE RESULT SHOWED THERE WERE NO ISSUES REPORTED AS MISSING LIDS DURING THE MANUFACTURING PROCESS REPORTED ADDITIONALLY. A REVIEW OF THE NCMR¿S WAS PERFORMED; THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE MISSING LIDS ISSUE FOR THE SAME PART NUMBER THROUGHOUT THE LAST TWELVE MONTHS. H3 OTHER TEXT: SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SHARPS COLL SLIDE CLOSE 19GAL PHARM WAS MISSING ITS LID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RMA ABOVE WAS CALLED IN BY CUSTOMER SERVICE DUE TO CUSTOMER COMPLAINT OF " MISSING LIDS"".

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS NOT REGISTERED WITH THE FDA. 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. MEDICAL DEVICE EXPIRATION DATE: NA. 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 SHARPS COLL SLIDE CLOSE 19GAL PHARM WAS MISSING ITS LID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RMA ABOVE WAS CALLED IN BY CUSTOMER SERVICE DUE TO CUSTOMER COMPLAINT OF " MISSING LIDS""

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1348331 SHARPS COLL SLIDE CLOSE 19GAL PHARM HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 305328 1204919 50382903053280

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown