BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGE

    MDR report key: 10901716 · Received November 25, 2020

    Report

    Report Number
    1920898-2020-01633
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Date of Event
    November 2, 2020
    Report Date
    December 4, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311748
    PMA / PMN Number
    K170386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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: 2020-11-18. INVESTIGATION SUMMARY: CUSTOMER RETURNED (2) 1CC, 8MM, 31G RELION SYRINGES IN AN OPEN POLY BAG FROM LOT#: 0013346. CUSTOMER STATES THAT THE NEEDLE HUB SEPARATED WHEN REMOVING SHIELD. BOTH RETURNED SYRINGES WERE EXAMINED AND BOTH EXHIBITED A BROKEN CANNULA. MICROSCOPIC EXAMINATION OF THE RETURNED SAMPLE REVEALED CHARACTERISTICS SUCH AS RESIDUAL BENDS ON THE BROKEN HUB END, CRACKED ADHESIVE, AND TUBING OVALITY (DEFORMATION FROM THE NORMALLY CIRCULAR CROSS SECTION). WHEN VIEWED TOGETHER, THESE ARE ALL INDICATORS OF BENDING/RE-STRAIGHTENING MODE OF FAILURE. REMOVAL OF SOME OF THE EPOXY MADE THIS OBSERVATION MORE APPARENT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0013346. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE IS BENDING / RE-STRAIGHTENING MODE OF FAILURE DONE BY THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 RELION® INSULIN SYRINGES EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SPOKE WITH CONSUMER TO CONFIRM PHARMACY ADDRESS. CONSUMER REPORTED, NEEDLE HUB SEPARATED WHEN REMOVING SHIELD. STATED, SHIELD WAS NOT HARD TO REMOVE. 2 SYRINGES AFFECTED. LOT: 0013346. CATALOG: 328506. 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 2 RELION® INSULIN SYRINGES EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SPOKE WITH CONSUMER TO CONFIRM PHARMACY ADDRESS. CONSUMER REPORTED, NEEDLE HUB SEPARATED WHEN REMOVING SHIELD. STATED, SHIELD WAS NOT HARD TO REMOVE 2 SYRINGES AFFECTED. LOT: 0013346, CATALOG: 328506, DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1366903 RELION INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328506 0013346 00681131311748

    Patients

    Seq Age Sex Outcome Treatment
    1