BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31G 6MM S/C U-100 RELION

    MDR report key: 11382377 · Received February 25, 2021

    Report

    Report Number
    1920898-2021-00228
    Event Type
    Malfunction
    Date Received
    February 25, 2021
    Date of Event
    February 2, 2021
    Report Date
    April 1, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131138383
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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: 2021-03-18. INVESTIGATION SUMMARY: CUSTOMER RETURNED (82) 3/10CC, 6MM, 31G RELION SYRINGES (2 LOOSE, 80 IN SEALED POLY BAGS) FROM LOT # 9140673. CUSTOMER STATES THAT THE NEEDLE BREAKS IN THE VIAL WHEN DRAWING THE INSULIN. THIRTY OUT OF 80 SYRINGES FROM THE SEALED POLY BAGS WERE EXAMINED AND NO DEFECTS WERE OBSERVED ON THE SAMPLES FROM THE SEALED POLY BAGS. BOTH LOOSE SAMPLES 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 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 ADHESIVE MADE THIS OBSERVATION MORE APPARENT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 9140673 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION NOTED FOR CRACKED HUBS. ROOT CAUSE IS USER RELATED, THE BENDING/RE-STRAIGHTENING MODE OF FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 0.3ML 31G 6MM S/C U-100 RELION NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 32852,1 BATCH NO: 9140673. IT WAS REPORTED THAT THE NEEDLE BREAKS IN THE VIAL WHEN DRAWING THE INSULIN.

    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 AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 0.3ML 31G 6MM S/C U-100 RELION NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328521 BATCH NO: 9140673. IT WAS REPORTED THAT THE NEEDLE BREAKS IN THE VIAL WHEN DRAWING THE INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277859 SYRINGE 0.3ML 31G 6MM S/C U-100 RELION PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328521 9140673 00681131138383

    Patients

    Seq Age Sex Outcome Treatment
    1