BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHARPS COLL 17L YELLOW

    MDR report key: 10690807 · Received October 16, 2020

    Report

    Report Number
    2243072-2020-01666
    Event Type
    Injury
    Date Received
    October 16, 2020
    Date of Event
    September 16, 2020
    Report Date
    February 9, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    MMK
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY THE COLLECTORS ARE NEEDLE PUNCTURE RESISTANT, NOT PUNCTURE PROOF. RETAIN SAMPLES OF THE LOT WERE TESTED AND SHOW THE COLLECTORS MEET SPECIFICATION. RETAIN SAMPLES OF THE BATCH 20204006 WERE REFERRED TO AND WALL THICKNESS MEASUREMENTS BY MAGNA MIKE SHOWED NO WALL THICKNESS DEVIATION BELOW THE WALL THICKNESS MINIMUM SPECIFICATION OF 1.18MM. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 20204006. WITHOUT ADDITIONAL EVIDENCE LIKE A PICTURE OF THE PENETRATION OR THE ACTUAL SAMPLE NO FURTHER INVESTIGATION WAS POSSIBLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SHARPS COLL 17L YELLOW EXPERIENCED SHARP PROTRUSION THROUGH SHARP CONTAINER WALL DURING USE. PRODUCT DEFECT RESULTED IN A DIRTY NEEDLE STICK INJURY. IT HAS NOT BEEN MENTIONED WHETHER MEDICAL INTERVENTION WAS APPLIED AS A RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE PIERCED CONTAINER. 30G NEEDLE PIERCED CONTAINER AND RESULTED IN NEEDLE STICK INJURY TO STAFF MEMBER. CONTAINER WAS REPORTED TO BE ONLY ONE QUARTER FILLED.

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS HDQ US (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. (B)(4). 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SHARPS COLL 17L YELLOW EXPERIENCED SHARP PROTRUSION THROUGH SHARP CONTAINER WALL DURING USE. PRODUCT DEFECT RESULTED IN A DIRTY NEEDLE STICK INJURY. IT HAS NOT BEEN MENTIONED WHETHER MEDICAL INTERVENTION WAS APPLIED AS A RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE PIERCED CONTAINER. 30G NEEDLE PIERCED CONTAINER AND RESULTED IN NEEDLE STICK INJURY TO STAFF MEMBER. CONTAINER WAS REPORTED TO BE ONLY ONE QUARTER FILLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157042 SHARPS COLL 17L YELLOW SHARPS CONTAINER MMK BECTON DICKINSON 20204006

    Patients

    Seq Age Sex Outcome Treatment
    1 Other