BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGE

    MDR report key: 11298524 · Received February 8, 2021

    Report

    Report Number
    1920898-2021-00168
    Event Type
    Malfunction
    Date Received
    February 8, 2021
    Date of Event
    January 19, 2021
    Report Date
    March 19, 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: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 2/9/2021. H.6. INVESTIGATION: CUSTOMER RETURNED TWO SYRINGES WITH NO POUCH FOR IDENTIFICATION. BOTH SYRINGES FEATURE 0.3ML MARKINGS. BOTH SYRINGES ARE MISSING THEIR NEEDLE SHIELD AND HUB. ONLY ONE NEEDLE SHIELD AND HUB SET WERE RETURNED. THE HUB WAS LODGED INSIDE THE SHIELD. THE CONNECTORS AT THE DISTAL TIPS OF THE SYRINGES WERE NOT DAMAGED, NOR WAS THE BASE OF THE RETURNED NEEDLE HUB. NO PLUNGER CAPS RETURNED BUT NO SIGNS OF USE. NO OTHER DEFECTS FOUND. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 9231336 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE NOTIFICATION [200872529] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WERE TWO NOTIFICATIONS [200872129, 200872284] NOTED FOR CRACKED HUBS. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. CAPA#1630423 WAS INITIATED.

    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 THAT THE NEEDLE HUB SEPARATED AND STAYED INSIDE OF THE SHIELD. LOT #: 9231336. CATALOG #: 328512.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. 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 THAT THE NEEDLE HUB SEPARATED AND STAYED INSIDE OF THE SHIELD. LOT #: 9231336, CATALOG #: 328512.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188389 RELION INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9231336

    Patients

    Seq Age Sex Outcome Treatment
    1