BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS COLL 22.7L YEL AU 1103 NON-VENT

    MDR report key: 10305930 · Received July 21, 2020

    Report

    Report Number
    2243072-2020-01120
    Event Type
    Malfunction
    Date Received
    July 21, 2020
    Date of Event
    July 1, 2020
    Report Date
    September 2, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    MMK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 7/28/2020. H.6. INVESTIGATION: DHR COULD NOT BE PERFORMED DUE TO UNKNOWN LOT#. A REVIEW OF THE NCMR¿S WAS PERFORMED; THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE ¿BROKEN LID¿ FOR THE SAME PART NUMBER THROUGHOUT THE LAST TWELVE MONTHS. BASED ON THE EVIDENCE RECEIVED, IT WAS CONCLUDED THE FOLLOWING: 1. THE PACKAGING USED WASN¿T THE ORIGINAL PACKAGING USED BY FLEX. 2. THE LID WAS BROKEN IN A CORNER. 3. THE BROKEN PIECE WAS FOUND INSIDE THE BOX. 4. THE LOT NUMBER (8130915) WAS CONFIRMED AS MANUFACTURED BY FLEX. 5. THE ISSUE REPORTED AS DEFECTIVE COVER, IT WAS CONFIRMED AS BROKEN LID. THE CURRENT MATERIAL WAS EVALUATED WITHIN THE PROCESS AND WAS FOUND THAT THE PRODUCT IS PACKAGED IN A SUITABLE BOX AND CONFIGURATION TO AVOID DAMAGES BY INTERACTIONS WITHIN THE BOX. BASED ON INFORMATION PROVIDED IT WASN¿T POSSIBLE DETERMINE THE ROOT CAUSE LIKE A FAILURE MODE RELATED TO THE MANUFACTURING PROCESS SINCE THERE IS NOT ENOUGH INFORMATION OR EVIDENCE TO CONFIRM A FAILURE. EVEN THOUGH, WE RECEIVED SAMPLE IT DIDN¿T COME IN THE ORIGINAL PACKAGING USED BY FLEX AND THE LID WAS BROKEN IN ONE SIDE, SO WE CANNOT FIND THE ROOT CAUSE OF THIS ISSUE, THIS TYPE OF DEFECTS ARE OUT OF REACH FROM MANUFACTURING PROCESS BECAUSE REPACKAGING PROCESS OR PARTIAL SALES ARE NOT ALLOWED TO BE SHIPPED TO CUSTOMER (THERE IS A STANDARD PACK PER BOX AND PALLET, AND THEY ARE LINKED TO PACKAGING DESIGN AND TYPE OF TRANSPORTATION).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SHARPS COLL 22.7L YEL AU 1103 NON-VENT EXPERIENCED A DAMAGED/DEFORMED LID/LID LOCK/LID LATCH. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEFECTIVE COVER.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4). 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 THE SHARPS COLL 22.7L YEL AU 1103 NON-VENT EXPERIENCED A DAMAGED/DEFORMED LID/LID LOCK/LID LATCH. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEFECTIVE COVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770327 SHARPS COLL 22.7L YEL AU 1103 NON-VENT SHARPS CONTAINER MMK BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other