BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS COLL MEXICO PUD 3.0L RED

    MDR report key: 11774098 · Received May 4, 2021

    Report

    Report Number
    2243072-2021-01343
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    April 6, 2021
    Report Date
    July 14, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    MMK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PHOTO OR SAMPLE REPRESENTATION WAS PROVIDED FOR THE COMPLAINT. A DHR REVIEW WAS PERFORMED AND SHOWED THERE WERE NO ISSUES REPORTED LIKE MISSING LIDS DURING THE MANUFACTURING PROCESS OF THE LOT NUMBER 0151943. A REVIEW OF NON-CONFORMING MATERIAL REPORT (NCMR) WAS PERFORMED FOR THIS PART FOR THE PAST 12 MONTHS AND NO ISSUES WERE REPORTED FOR MISSING LIDS FOR THE SAME PART NUMBER. ACCORDING TO THIS INVESTIGATION, MORE INFORMATION LIKE A PHYSICAL SAMPLE AND OR PHOTO EVIDENCE IS NECESSARY TO DETERMINE HOW THIS FAILURE OCCURED. POTENTIAL ROOT CAUSES INCLUDE: NON-CONTROLLED METHOD TO SHIP PARTIAL BOXES TO END USER, MISSING CONTROL DURING THE RE-PACKAGING PROCESS WITH THE DISTRIBUTOR, OR INCORRECT PACKAGING AT THE TIME TO PERFORM PARTIAL SALES. BD WILL CONTINUE TO MONITOR FOR ANY TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 SHARPS COLL MEXICO PUD 3.0L RED EXPERIENCED MISSING LIS OR SLIDE LIDS/CLAMPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SHARPS COLLECTOR ARRIVED WITHOUT CAPS. 4 UNITS.

    Additional Manufacturer Narrative · 1

    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. MEDICAL DEVICE EXPIRATION DATE: NA. INITIAL REPORTER ADDR 1: (B)(4). 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 4 SHARPS COLL MEXICO PUD 3.0L RED EXPERIENCED MISSING LIS OR SLIDE LIDS/CLAMPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SHARPS COLLECTOR ARRIVED WITHOUT CAPS. 4 UNITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665699 SHARPS COLL MEXICO PUD 3.0L RED SHARPS COLLECTOR MMK BECTON DICKINSON 0151943

    Patients

    Seq Age Sex Outcome Treatment
    1