BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS

    MDR report key: 11152996 · Received January 12, 2021

    Report

    Report Number
    1920898-2021-00030
    Event Type
    Malfunction
    Date Received
    January 12, 2021
    Date of Event
    December 15, 2020
    Report Date
    February 19, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K170386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. 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# 5306827, 5341833 AND 7170641. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. THIS BATCH WAS MANUFACTURED BEFORE EXPIRATION DATES WERE PRINTED ON PACKAGING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS WAS MISSING LABEL INFORMATION ON 5 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: BATCH NO: 5341833,7170641,5306827, UNKNOWN (REPORTED 6074107). IT WAS REPORTED THAT THE CONSUMER HAS FIVE BOXES OF SYRINGES WITHOUT THE EXPIRATION DATE. IS CURRENTLY USING LOT#5341833. VERBATIM: SPOUSE OF CONSUMER REPORTED HAVING 5 BOXES OF SYRINGES WITH NO EXPIRATION DATES ON THEM. STATED ALL BOXES HAVE A TRADEMARK DATE OF 2014. STATED THE CONSUMER IS USING THE 30 G, 12.7MM, 1 ML BD SYRINGES. STATED BD SHOULD BE REPLACING THESE BOXES BECAUSE THEY DO NOT HAVE AN EXPIRATION DATE ON THEM. STATED SHE IS ALSO DISAPPOINTED THAT SHE CALLED THIS MORNING AND IT SAID THE BD CARES TEAM WAS IN A TEAM MEETING. STATED THE BD WEBSITE IS ALSO NOT USER FRIENDLY AND SHE FINALLY MANAGED TO SEND AN EMAIL. ADVISED SPOUSE THAT BD TESTS THE PRODUCTS FOR 5 YEARS AND IT IS NOT RECOMMENDED TO USE EXPIRED PRODUCT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE LOT #: THE CUSTOMER PROVIDED LOT # 6074107. THIS DOES NOT MATCH THE CATALOG NUMBER PROVIDED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 5341833, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 2016-02-01. MEDICAL DEVICE LOT #: 7170641, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 2017-08-02. MEDICAL DEVICE LOT #: 5306827, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 2016-01-06. MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6), USA HAS BEEN USED AS A DEFAULT. 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 1.0ML 30GA 1/2IN UF 10BAG 500CS WAS MISSING LABEL INFORMATION ON 5 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: BATCH NO: 5341833,7170641,5306827, UNKNOWN (REPORTED (B)(4)). IT WAS REPORTED THAT THE CONSUMER HAS FIVE BOXES OF SYRINGES WITHOUT THE EXPIRATION DATE. IS CURRENTLY USING LOT#5341833. VERBATIM: SPOUSE OF CONSUMER REPORTED HAVING 5 BOXES OF SYRINGES WITH NO EXPIRATION DATES ON THEM. STATED ALL BOXES HAVE A TRADEMARK DATE OF 2014. STATED THE CONSUMER IS USING THE 30 G, 12.7MM, 1 ML BD SYRINGES. STATED BD SHOULD BE REPLACING THESE BOXES BECAUSE THEY DO NOT HAVE AN EXPIRATION DATE ON THEM. STATED SHE IS ALSO DISAPPOINTED THAT SHE CALLED THIS MORNING AND IT SAID THE BD CARES TEAM WAS IN A TEAM MEETING. STATED THE BD WEBSITE IS ALSO NOT USER FRIENDLY AND SHE FINALLY MANAGED TO SEND AN EMAIL. ADVISED SPOUSE THAT BD TESTS THE PRODUCTS FOR 5 YEARS AND IT IS NOT RECOMMENDED TO USE EXPIRED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52846 SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1