BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP

    MDR report key: 10614251 · Received October 1, 2020

    Report

    Report Number
    1920898-2020-01338
    Event Type
    Injury
    Date Received
    October 1, 2020
    Date of Event
    September 11, 2020
    Report Date
    October 6, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (1) 3/10CC, 12.7MM, 29G SYRINGE IN AN OPEN POLY BAG FROM LOT # 9231316. CUSTOMER STATES THAT THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE HUB, THEY INJURED THEIR FINGER, AND THERE WAS BLEEDING. THE RETURNED SYRINGE WAS TESTED AND THE HUB ASSEMBLY DID NOT SEPARATE FROM THE BARREL WHEN REMOVING THE SHIELD. NO DEFECTS WERE OBSERVED ON THE SAMPLE THAT MAY HAVE LED TO A NEEDLE STICK OR BLEEDING. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9231316. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200842714] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP HUB SEPARATED ON 2 OCCASIONS BEFORE USE. WHEN HANDLING THE COMPONENTS THE CUSTOMER'S FINGER WAS INJURED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT TWO ISSUES, HUB SEPARATION AND HARM OF FINGER. THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE HUB. AFTER THAT, WHEN HANDLING THE AFFECTED COMPONENTS, THE CUSTOMER INJURED HIS/HER FINGER. HE/SHE HAD BLEEDING BUT IT WAS MILD INSEVERITY. NO INFORMATION ON WHETHER THE SHIELD WAS TIGHT TO REMOVE OR NOT WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    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 SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP HUB SEPARATED ON 2 OCCASIONS BEFORE USE. WHEN HANDLING THE COMPONENTS THE CUSTOMER'S FINGER WAS INJURED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT TWO ISSUES, HUB SEPARATION AND HARM OF FINGER. THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE HUB. AFTER THAT, WHEN HANDLING THE AFFECTED COMPONENTS, THE CUSTOMER INJURED HIS/HER FINGER. HE/SHE HAD BLEEDING BUT IT WAS MILD IN SEVERITY. NO INFORMATION ON WHETHER THE SHIELD WAS TIGHT TO REMOVE OR NOT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1081209 SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP SYRINGE FMF BD MEDICAL - DIABETES CARE 9231316

    Patients

    Seq Age Sex Outcome Treatment
    1 Other