BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG

    MDR report key: 8879061 · Received August 9, 2019

    Report

    Report Number
    1920898-2019-00786
    Event Type
    Injury
    Date Received
    August 9, 2019
    Date of Event
    July 25, 2019
    Report Date
    September 3, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00311917048154
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8232713. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FOUR (4) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CONSUMER SUSTAINED A NEEDLE STICK INJURY FROM THE SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG DURING USE WHILE ATTEMPTING TO RESHIELD THE NEEDLE AFTER HAVING GIVEN HER PET AN INJECTION. NO MEDICAL INTERVENTION WAS REPORTED, AND THE CONSUMER REPORTEDLY "DOES NOT PLAN" ON SEEKING IT OUT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PET OWNER REPORTED STICKING HER FINGER WHEN SHE RE-SHIELD AFTER GIVING PET INJECTION. STATED: DID NOT KNOW SHE SHOULD NOT RE-SHIELD STATED: THERE WAS BLEEDING BUT IT STOPPED SOON AFTER. NO MEDICAL ATTENTION RECEIVED. DOES NOT PLAN ON SEEKING MEDICAL OR RE-SHIELDING GOING FORWARD. LOT: 8232713 EXPIRATION DATE: 2023-08 INCIDENT OCCURRED THIS MORNING, (B)(6) 2019 STATED SHE HAS STUCK HERSELF A COUPLE OF TIMES IN PAST BUT DOES NOT HAVE SPECIFIC DATE OR LOT TO PROVIDE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONSUMER SUSTAINED A NEEDLE STICK INJURY FROM THE SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG DURING USE WHILE ATTEMPTING TO RESHIELD THE NEEDLE AFTER HAVING GIVEN HER PET AN INJECTION. NO MEDICAL INTERVENTION WAS REPORTED, AND THE CONSUMER REPORTEDLY "DOES NOT PLAN" ON SEEKING IT OUT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PET OWNER REPORTED STICKING HER FINGER WHEN SHE RE-SHIELD AFTER GIVING PET INJECTION. STATED: DID NOT KNOW SHE SHOULD NOT RE-SHIELD. STATED: THERE WAS BLEEDING BUT IT STOPPED SOON AFTER. NO MEDICAL ATTENTION RECEIVED. DOES NOT PLAN ON SEEKING MEDICAL OR RE-SHIELDING GOING FORWARD. LOT: 8232713, EXPIRATION DATE: 08/2023, INCIDENT OCCURRED THIS MORNING, (B)(6) 2019. STATED SHE HAS STUCK HERSELF A COUPLE OF TIMES IN PAST BUT DOES NOT HAVE SPECIFIC DATE OR LOT TO PROVIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672849 SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8232713 00311917048154

    Patients

    Seq Age Sex Outcome Treatment
    1 Other