BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 31GA 6MM 10 BAG 500 SLA

    MDR report key: 11838935 · Received May 17, 2021

    Report

    Report Number
    1920898-2021-00566
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Date of Event
    April 19, 2021
    Report Date
    July 16, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED AN IMAGE A SHELF CARTON FOR 0.5ML, 31 GAUGE, 6MM SYRINGES FROM LOT 0083432. THE SHIPPING INFORMATION STATES THAT THE FABRICATION DATE IS 2020-03-23. HOWEVER, PER MANUFACTURING SITE HOLDREGE¿S RECORDS, LOT. NO. 0083432 WAS MANUFACTURED IN APRIL 2020. THIS MANUFACTURING DATE CORRESPONDS WITH THE DATE ON THE CARTON. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0083432. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. DATE(S) OF PACKAGING: 13MAY2020 TO 15MAY2020. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE IMAGE RECEIVED, BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF A DISCREPANCY BETWEEN THE MANUFACTURING DATE PRINTED ON THE SHELF CARTON AND THE ACTUAL MANUFACTURING DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYRINGE 0.5ML 31GA 6MM 10 BAG 500 SLA HAD INCORRECT LABEL INFORMATION BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "DIVERGENCE OF MANUFACTURING DATE BETWEEN INVOICE AND PRODUCT. DATE DESCRIBED IN THE INVOICE: 03/23/2020. DATE DESCRIBED ON THE PRODUCT: 04/23/2020".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYRINGE 0.5ML 31GA 6MM 10 BAG 500 SLA HAD INCORRECT LABEL INFORMATION BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "DIVERGENCE OF MANUFACTURING DATE BETWEEN INVOICE AND PRODUCT. DATE DESCRIBED IN THE INVOICE: (B)(6) 2020 DATE DESCRIBED ON THE PRODUCT: (B)(6) 2020 "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729399 SYRINGE 0.5ML 31GA 6MM 10 BAG 500 SLA PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0083432

    Patients

    Seq Age Sex Outcome Treatment
    1