BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL

    MDR report key: 8787180 · Received July 12, 2019

    Report

    Report Number
    1920898-2019-00659
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    June 27, 2019
    Report Date
    August 7, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311748
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (20) 1CC, 8MM, 31G RELION SYRINGES (10 LOOSE, 10 IN A SEALED POLY BAG) FROM LOT # 8190574. CUSTOMER STATES THAT AFTER INJECTION IN BOTH HER LEFT AND RIGHT THIGH, SHE NOTICED "RED STREAKS" THAT LATER BECAME "WARM" TO THE TOUCH AND "ITCHY". ALL RETURNED SYRINGES WERE TESTED FOR POINT GEOMETRY, LUBE, AND CANNULA OD (SPECS: OUTER DIAMETER FOR 31G: 0.0100¿-0.0105¿). ALL OBSERVATIONS FALL WITHIN SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8190574. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOUR SYRINGES 1.0ML 31GA 8MM 10BAG 500 WAL CAUSED AN ALLERGIC REACTION AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 328506 BATCH NO.: 8190574 COMPLAINT 2 OF 2: DATE OF OCCURRENCE 27-JUN-2019. VERBATIM: CONSUMER STATED: AFTER INJECTION IN BOTH HER LEFT AND RIGHT THIGH, SHE NOTICED "RED STREAKS" THAT LATER BECAME "WARM" TO THE TOUCH AND "ITCHY". IT HAPPENED ON 06/27/19. 4 SYRINGES WERE USED. NO MEDICATION OR FOLLOW UP VISITS NECESSARY AND SHE WIPES THE NEEDLE WITH A ALCOHOL SWAB BEFORE USE. STATED ONCE THE ITCHING STOPS AND REDNESS GOES AWAY, A BRUISE IS LEFT BEHIND.

    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 FOUR SYRINGES 1.0 ML 31GA 8 MM 10BAG 500 WAL CAUSED AN ALLERGIC REACTION AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 328506. BATCH NO.: 8190574. COMPLAINT 2 OF 2: DATE OF OCCURRENCE (B)(6) 2019. VERBATIM: CONSUMER STATED: AFTER INJECTION IN BOTH HER LEFT AND RIGHT THIGH, SHE NOTICED "RED STREAKS" THAT LATER BECAME "WARM" TO THE TOUCH AND "ITCHY". IT HAPPENED ON (B)(6) 2019. 4 SYRINGES WERE USED. NO MEDICATION OR FOLLOW UP VISITS NECESSARY AND SHE WIPES THE NEEDLE WITH A ALCOHOL SWAB BEFORE USE. STATED ONCE THE ITCHING STOPS AND REDNESS GOES AWAY, A BRUISE IS LEFT BEHIND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580733 SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8190574 00681131311748

    Patients

    Seq Age Sex Outcome Treatment
    1 Other