BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 30G 8MM

    MDR report key: 12242685 · Received July 28, 2021

    Report

    Report Number
    1920898-2021-00829
    Event Type
    Malfunction
    Date Received
    July 28, 2021
    Date of Event
    June 29, 2021
    Report Date
    July 29, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-08-24. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (4) LOOSE 3/10CC, 8MM, 30G SYRINGES WITH THE SHELF CARTON FROM LOT # 0090628. CUSTOMER STATES THAT WHEN THE PROTECTIVE CAP IS REMOVED FROM THE SYRINGE, THE ATTACHED NEEDLE IS ALSO REMOVED. ALL RETURNED SYRINGES WERE EXAMINED AND 3 OUT OF 4 SAMPLES EXHIBITED THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. NO DEFECTS WERE OBSERVED ON THE REMAINING SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0090628. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE UB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. CAPA PR1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 SYRINGE 0.3ML 30G 8MM HUB SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE DISTRIBUTOR REPORTED THAT WHEN THE PROTECTIVE CAP IS REMOVED FROM THE SYRINGE THE ATTACHED NEEDLE IS ALSO REMOVED. THIS ISSUE WAS IDENTIFIED ON (B)(6) 2021.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE# : (B)(6). INITIAL REPORTER ZIP CODE : (B)(6). A DEVICE EVALUATION IS PENDING 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 1 SYRINGE 0.3ML 30G 8MM HUB SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE DISTRIBUTOR REPORTED THAT WHEN THE PROTECTIVE CAP IS REMOVED FROM THE SYRINGE THE ATTACHED NEEDLE IS ALSO REMOVED. THIS ISSUE WAS IDENTIFIED ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1135280 SYRINGE 0.3ML 30G 8MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0090628

    Patients

    Seq Age Sex Outcome Treatment
    1