BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS COLL 19GAL RED

    MDR report key: 10839997 · Received November 13, 2020

    Report

    Report Number
    2243072-2020-01823
    Event Type
    Malfunction
    Date Received
    November 13, 2020
    Date of Event
    October 20, 2020
    Report Date
    December 9, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903056095
    PMA / PMN Number
    K943575
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 0114942. INVESTIGATION SUMMARY: PHOTO REPRESENTATION WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE REPORTED LOT WAS PERFORMED AND THERE WERE NO ISSUES FOUND FOR MISSING LIDS DURING THE MANUFACTURING PROCESS OF THE REPORTED LOT. A REVIEW OF NON-CONFORMING MATERIAL REPORT (NCMR) WAS PERFORMED FOR THE LAST TWELVE MONTHS AND DID NOT IDENTIFY ANY NONCONFORMANCE. AS CORRECTIVE ACTION A WEIGHING SYSTEM HAS ALREADY BEEN IMPLEMENTED FOR THIS CONTAINER MANUFACTURING PROCESS TO ENSURE THE CORRECT QUANTITY OF PIECES PER BOX BEFORE SHIPPING. ALL WEIGHT CHECKS FOR THIS LOT APPEAR TO HAVE MET REQUIREMENTS AT THE TIME OF MANUFACTURING WITH LIDS. THE ROOT CAUSE IS UNKNOWN. THE LIDS COULD BE MISPLACED, OR AN ERROR OCCURRED BY A 3RD PARTY IF REPACKAGING FOR DISTRIBUTION. THIS COMPLAINT MAY HAVE OCCURRED FROM A PARTIAL SALE SOLD BY THE DISTRIBUTOR. ADDITIONAL INFORMATION ABOUT THE HANDLING AND STORAGE BY THE DISTRIBUTOR FACILITY TO RULE OUT THAT THE ISSUE WAS NOT DUE TO INCORRECT HANDLING OR A PARTIAL SALE IS REQUIRED. BASED ON THESE FINDINGS, OUR INVESTIGATION IS INCONCLUSIVE. BD WILL CONTINUE TO MONITOR FOR ANY TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SHARPS COLL 19GAL RED EXPERIENCED THE LID OR SLIDE LID/CLAMP MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305609 BATCH NO: UNKNOWN. CUST RECEIVED ITEM 03395670 WITHOUT LIDS. PER VENDOR , LIDS SHOULD BE IN PACKAGING /(B)(4) REPLACEMENT PO #D02886234. CUSTOMER IS HOLDING THE PRODUCT IF NEEDED TO RETURN.

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SHARPS COLL 19GAL RED EXPERIENCED THE LID OR SLIDE LID/CLAMP MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305609, BATCH NO: UNKNOWN. CUST RECIEVED ITEM (B)(4) WITHOUT LIDS. PER VENDOR , LIDS SHOULD BE IN PACKAGING /(B)(4), REPLACEMENT PO #(B)(4). CUSTOMER IS HOLDIONG THE PRODUCT IF NEEDED TO RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305866 SHARPS COLL 19GAL RED HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 305609 0114942 00382903056095

    Patients

    Seq Age Sex Outcome Treatment
    1