BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB

    MDR report key: 10312869 · Received July 23, 2020

    Report

    Report Number
    1920898-2020-00921
    Event Type
    Injury
    Date Received
    July 23, 2020
    Date of Event
    July 2, 2020
    Report Date
    July 28, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    30382903059455
    PMA / PMN Number
    K992734
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 6131957. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB EXPERIENCED A BROKEN SAFETY MECHANISM, BLOOD EXPOSURE-SPLASH, AND A POST USE DIRTY NEEDLE STICK INJURY. PRODUCT DEFECTS WERE NOTED AFTER USE. IT HAS NOT BEEN SPECIFIED WHETHER ANY MEDICAL INTERVENTION WAS RECEIVED AS A RESULT OF THE NEEDLE STICK INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305945. BATCH NO: 6131957. SAFETY GLIDE NEEDLE COVER DEPLOYED AFTER TB SKIN TEST PERFORMED. ABLE TO UNLOCK SAFETYGLIDE COVER WHICH SLID BACK AND RESULTED IN A NEEDLESTICK INJURY.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB EXPERIENCED A BROKEN SAFETY MECHANISM, BLOOD EXPOSURE -SPLASH, AND A POST USE DIRTY NEEDLE STICK INJURY. PRODUCT DEFECTS WERE NOTED AFTER USE. IT HAS NOT BEEN SPECIFIED WHETHER ANY MEDICAL INTERVENTION WAS RECEIVED AS A RESULT OF THE NEEDLE STICK INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305945 BATCH NO: 6131957. SAFETY GLIDE NEEDLE COVER DEPLOYED AFTER TB SKIN TEST PERFORMED. ABLE TO UNLOCK SAFETYGLIDE COVER WHICH SLID BACK AND RESULTED IN A NEEDLESTICK INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777791 SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB SYRINGE FMF BD MEDICAL - DIABETES CARE 305945 6131957 30382903059455

    Patients

    Seq Age Sex Outcome Treatment
    1 Other