BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS COLL 8QT NEST OPEN TOP NEEDL PORT

    MDR report key: 12230236 · Received July 27, 2021

    Report

    Report Number
    2243072-2021-01966
    Event Type
    Malfunction
    Date Received
    July 27, 2021
    Date of Event
    June 28, 2021
    Report Date
    August 19, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    50382903053433
    PMA / PMN Number
    K943134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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. CUSTOMER PROVIDED PICTURES. ACCORDING WITH THE EVIDENCE RECEIVED, THIS INVESTIGATION CAN´T BE COMPLETED DUE THE LACK OF INFORMATION PROVIDED BUT WITH THE INFORMATION COLLECTED OF THE REPORT FROM THE USER (MUSASHINOKAI MEDICAL CORPORATION TGM ASA) THE INVESTIGATION WAS CONCLUDED THAT THIS PRODUCT HAD HANDLING BY A DISTRIBUTOR DUE THE PACKAGE REPORTED WAS FOR 24 PIECES BUT THE OCCURRENCE ONLY MENTIONED THIS ISSUE IN 2 PIECES. FOR THIS REASON, IT CAN BE CONCLUDED THAT THERE ARE MANY VARIABLES THAT COULD GENERATE THIS FAILURE MODE BECAUSE THE DISTRIBUTORS CAN DO PARTIAL SELLS AND THE CONTROLS TO HANDLE REMAINING MATERIAL IS UNKNOWN, THEREFORE, THE LIKELIHOOD OF NON-CONTROLLED HANDLING WITHIN DISTRIBUTOR FACILITIES COULD HAPPEN. 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 LIDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 SHARPS COLL 8QT NEST OPEN TOP NEEDL PORT HAD MISSING LIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS A REPORT ABOUT MISSING LIDS OF SHARPS COLLECTORS."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS FLEXTRONICS. 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 2 SHARPS COLL 8QT NEST OPEN TOP NEEDL PORT HAD MISSING LIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS A REPORT ABOUT MISSING LIDS OF SHARPS COLLECTORS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1123933 SHARPS COLL 8QT NEST OPEN TOP NEEDL PORT HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 305343 0315935 50382903053433

    Patients

    Seq Age Sex Outcome Treatment
    1