BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30 ML BD LUER-LOK TIP SYRINGE

    MDR report key: 9787759 · Received March 4, 2020

    Report

    Report Number
    1911916-2020-00211
    Event Type
    Malfunction
    Date Received
    March 4, 2020
    Date of Event
    February 13, 2020
    Report Date
    March 6, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028321
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 1 SAMPLE WAS RECEIVED. NO PHOTO WAS PROVIDED. ONE SAMPLE WAS RECEIVED. IT CAME IN AN OPEN PACKAGING BLISTER. VISUAL INSPECTION WAS PERFORMED. IT HAS THE PLUNGER ROD THUMB PRESS DAMAGED. NO DEFECTS OR DAMAGES WERE OBSERVED IN ANY OTHER AREA. THIS WOULD HAVE HAPPENED DURING SYRINGE ASSEMBLY PROCESS. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 30 ML BD LUER-LOK¿ TIP SYRINGE WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 302832 BATCH NO.: UNKNOWN (PROVIDED 924053). IT WAS REPORTED THE TOP OF THE SYRINGE WAS BROKEN OFF CREATING A VERY SHARP EDGE. VERBATIM: TOP OF SYRINGE WAS BROKEN OFF CREATING A VERY SHARP EDGE. THE NURSE ALMOST CUT HER HAND ON IT.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 30 ML BD LUER-LOK¿ TIP SYRINGE WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 302832 BATCH NO.: UNKNOWN (PROVIDED 924053). IT WAS REPORTED THE TOP OF THE SYRINGE WAS BROKEN OFF CREATING A VERY SHARP EDGE. VERBATIM: TOP OF SYRINGE WAS BROKEN OFF CREATING A VERY SHARP EDGE. THE NURSE ALMOST CUT HER HAND ON IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253436 30 ML BD LUER-LOK TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 302832 UNKNOWN 30382903028321

    Patients

    Seq Age Sex Outcome Treatment
    1 Other