BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 30GA 8MM 10BAG 500 PL/WG

    MDR report key: 11248512 · Received January 28, 2021

    Report

    Report Number
    1920898-2021-00129
    Event Type
    Malfunction
    Date Received
    January 28, 2021
    Date of Event
    January 8, 2021
    Report Date
    March 3, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00311917025292
    PMA / PMN Number
    K024112
    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# 5152535. 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 A SYRINGE 1.0ML 30GA 8MM 10BAG 500 PL/WG HAD MISSING LABEL INFORMATION BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT EXPIRATION DATE IS MISSING FROM SHELF CARTON. (B)(4) RECORDS ISSUE IF MISSING EXPIRATION DATE FOR CAT 928853. (B)(4) RECORDS ISSUE IF MISSING EXPIRATION DATE FOR CAT 928854. VERBATIM: WALGREEN'S PHARMACIST STATED HE HAD 3 BOXES OF INSULIN SYRINGES WITHOUT EXPIRATION DATES. ADVISED THAT THE PRODUCT BOXES COULD BE EXPIRED.".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN THE CUSTOMER'S ADDRESS IS UNKNOWN. NEW JERSEY (NJ), 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 A SYRINGE 1.0ML 30GA 8MM 10BAG 500 PL/WG HAD MISSING LABEL INFORMATION BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT EXPIRATION DATE IS MISSING FROM SHELF CARTON. PR 2271243 RECORDS ISSUE IF MISSING EXPIRATION DATE FOR CAT 928853. PR 2276138 RECORDS ISSUE IF MISSING EXPIRATION DATE FOR CAT 928854. VERBATIM: WALGREEN'S PHARMACIST STATED HE HAD 3 BOXES OF INSULIN SYRINGES WITHOUT EXPIRATION DATES. ADVISED THAT THE PRODUCT BOXES COULD BE EXPIRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144627 SYRINGE 1.0ML 30GA 8MM 10BAG 500 PL/WG PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 928853 5152538 00311917025292

    Patients

    Seq Age Sex Outcome Treatment
    1