BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 30G 8MM

    MDR report key: 12255558 · Received July 30, 2021

    Report

    Report Number
    1920898-2021-00835
    Event Type
    Malfunction
    Date Received
    July 30, 2021
    Date of Event
    July 1, 2021
    Report Date
    July 12, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    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 · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: LOT #: 9176501  DEVICE EXPIRATION DATE: 07/31/2024.  DEVICE MANUFACTURE DATE: 06/25/2019. LOT #: 9266924  DEVICE EXPIRATION DATE: 09/30/2024.  DEVICE MANUFACTURE DATE: 09/23/2019. LOT #: 0090628  DEVICE EXPIRATION DATE: 04/30/2025.  DEVICE MANUFACTURE DATE: 03/30/2020. INITIAL REPORTER CITY AND STATE: (B)(6). INITIAL REPORTER ZIP CODE: (B)(6). INVESTIGATION SUMMARY: EXEC SUMMARY - NO PHYSICAL SAMPLES WERE RECEIVED; THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTO PROVIDED. EXAMINATION OF THE PHOTOS INDICATES THAT THE STOPPER LEADING EDGE WAS SLIGHTLY ANGLED TO ONE SIDE IN THE BARREL AND NOT STRAIGHT ACROSS. CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMERS INDICATED FAILURE BASED ON THE PHOTOS RECEIVED. CAPA/SA - BASED ON THE ABOVE NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) ARE REQUIRED AT THIS TIME. DHR REVIEW - DEVICE HISTORY (DHR) FOR BATCH 0090628, 9176501 AND 9266924 WERE REVIEWED. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 SYRINGE 0.3ML 30G 8MM HAD DEFORMED STOPPER ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER PROVIDED PHOTOS AND DURING INVESTIGATION OF THE PROVIDED PHOTOS 1 ADDITIONAL ISSUE OF "STOPPER DISFIGURED" WAS OBSERVED. PICTURES ONLY - SAMPLE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1147992 SYRINGE 0.3ML 30G 8MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE

    Patients

    Seq Age Sex Outcome Treatment
    1