BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHARPS COLL 1.4L YELLOW TRAY SIZE

    MDR report key: 11340711 · Received February 17, 2021

    Report

    Report Number
    2243072-2021-00345
    Event Type
    Injury
    Date Received
    February 17, 2021
    Date of Event
    January 21, 2021
    Report Date
    May 4, 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: 3 PHOTOS WERE RECEIVED AND PRESENTED TO THE SUPPLIER IN REPRESENTATION OF THIS COMPLAINT. AFTER MULTIPLE ATTEMPTS THE DHR WAS NOT AVAILABLE AFTER MULTIPLE ATTEMPTS TO RETRIEVE IT. ACCORDING TO THIS INVESTIGATION, RETAINED SAMPLES OF THE SAME BATCH WERE RETRIEVED AND THE WALL THICKNESS WAS ABOVE THE MINIMUM SPECIFICATIONS OF 1.2MM, MEASURING BETWEEN 1.6 AND 1.7MM. THESE CONTAINERS ARE DESIGNED TO WITHSTAND A FORCE OF 12.5N (NEWTONS) BEFORE PENETRATION IS ACHIEVED. IT IS BELIEVED THAT THE ROOT CAUSE OF THIS FAILURE WAS A FORCE WHICH EXCEEDED THIS MINIMUM THRESHOLD WHILE NEEDLES WERE DISPOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHARPS COLL 1.4L YELLOW TRAY SIZE WAS PERFORATED BY A NEEDLE AND CAUSED A NEEDLESTICK INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SHARPS CONTAINER WAS PERFORATED BY A NEEDLE SHARP, STAFF MEMBER SUSTAINED NEEDLESTICK INJURY. THE SHARPS CONTAINER WAS NOT OVERFULL AND WHEN I SHOOK THE CONTAINER GENTLY, IT WAS MAINLY FILLED WITH PURPLE UNISTIK SAFETY LANCETS. IT APPEARED TO BE A SOLID TIP BUT HAD BEEN SPLAYED FROM PUSHING THROUGH THE PLASTIC. A STAFF MEMBER SUSTAINED A NEEDLE STICK FROM THE SHARP AND THEY HAVE THE STAFF MEMBER ON THEIR BBFE FOLLOW UP. THE SHARPS CONTAINER HAS BEEN DISPOSED OF IN THE THEATRE SHARPS BIN TO AVOID FURTHER BBFE.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS HDQ US (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHARPS COLL 1.4L YELLOW TRAY SIZE WAS PERFORATED BY A NEEDLE AND CAUSED A NEEDLESTICK INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SHARPS CONTAINER WAS PERFORATED BY A NEEDLE SHARP, STAFF MEMBER SUSTAINED NEEDLESTICK INJURY. THE SHARPS CONTAINER WAS NOT OVERFULL AND WHEN I SHOOK THE CONTAINER GENTLY, IT WAS MAINLY FILLED WITH PURPLE UNISTIK SAFETY LANCETS. IT APPEARED TO BE A SOLID TIP BUT HAD BEEN SPLAYED FROM PUSHING THROUGH THE PLASTIC. A STAFF MEMBER SUSTAINED A NEEDLE STICK FROM THE SHARP AND THEY HAVE THE STAFF MEMBER ON THEIR BBFE FOLLOW UP. THE SHARPS CONTAINER HAS BEEN DISPOSED OF IN THE THEATRE SHARPS BIN TO AVOID FURTHER BBFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236523 SHARPS COLL 1.4L YELLOW TRAY SIZE SHARPS CONTAINER MMK BECTON DICKINSON 20275001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other