BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGE

    MDR report key: 11060836 · Received December 22, 2020

    Report

    Report Number
    1920898-2020-01745
    Event Type
    Malfunction
    Date Received
    December 22, 2020
    Date of Event
    November 25, 2020
    Report Date
    February 9, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    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: 2021-01-11. H6: INVESTIGATION SUMMARY. CUSTOMER RETURNED (1) LOOSE 3/10CC SYRINGE. CUSTOMER STATES THAT THE NEEDLE HUB SEPARATED INTO SHIELD. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 9210510 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200837337, 200837237] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION [200837775] NOTED FOR OUT OF SPEC SHIELD PULL. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE THAT THE NEEDLE HUB SEPARATED INTO SHIELD. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. CAPA1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RELION® INSULIN SYRINGE EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:CONSUMER REPORTED FOUND 1 NEEDLE FROM THIS BOX THAT STAYED IN THE SHIELD WHEN REMOVEDLOT #: 9210510. CATALOG#: 328512.DATE OF EVENT: UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RELION® INSULIN SYRINGE EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FOUND 1 NEEDLE FROM THIS BOX THAT STAYED IN THE SHIELD WHEN REMOVED LOT #: 9210510. CATALOG#: 328512. DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1523765 RELION INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9210510

    Patients

    Seq Age Sex Outcome Treatment
    1