BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11712793 · Received April 23, 2021

    Report

    Report Number
    1920898-2021-00448
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 26, 2021
    Report Date
    May 10, 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
    MN, US
    Reporter Occupation
    003

    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: 4/30/2021. H.6. INVESTIGATION: CUSTOMER RETURNED (1) LOOSE 0.3ML INSULIN SYRINGE. THE CUSTOMER REPORTED THAT THE NEEDLE SHIELDS ARE DIFFICULT TO REMOVE, AND THE NEEDLE HUB SEPARATED WHEN REMOVING NEEDLE SHIELD PRIOR TO INJECTION. THE RETURNED SYRINGE WAS EXAMINED, AND IT WAS OBSERVED THAT THE NEEDLE HUB/SHIELD ASSEMBLY WAS SEPARATED FROM THE RETURNED BARREL. NO DAMAGE TO THE BARREL TIP WAS OBSERVED. IT WAS OBSERVED THAT 2 SEPARATED NEEDLE HUB ASSEMBLIES WERE RETURNED WITH 1 SYRINGE BARREL ASSEMBLY. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0132212 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 RAISED SHIELDS. CAPA#1630423 WAS INITIATED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.3ML 31G 6MM S/C U-100 RELION SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLE SHIELDS ARE DIFFICULT TO REMOVE AND NEEDLE HUB SEPARATED FROM SYRINGE. VERBATIM: RELION PET OWNER REPORTED, NEEDLE SHIELDS ARE DIFFICULT TO REMOVE REPORTED, NEEDLE HUB SEPARATED WHEN REMOVING NEEDLE SHIELD PRIOR TO INJECTION STATED, DISCARDED MOST OF THE SYRINGES THAT WERE AFFECTED BUT HELD ONTO THE ONE FROM THIS MORNING."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED, AND ONE NON-CONFORMANCE WAS RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.3ML 31G 6MM S/C U-100 RELION SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLE SHIELDS ARE DIFFICULT TO REMOVE AND NEEDLE HUB SEPARATED FROM SYRINGE. VERBATIM: RELION PET OWNER REPORTED, NEEDLE SHIELDS ARE DIFFICULT TO REMOVE REPORTED, NEEDLE HUB SEPARATED WHEN REMOVING NEEDLE SHIELD PRIOR TO INJECTION STATED, DISCARDED MOST OF THE SYRINGES THAT WERE AFFECTED BUT HELD ONTO THE ONE FROM THIS MORNING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613635 SYRINGE 0.3ML 31G 6MM S/C U-100 RELION PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328521 0132212 00681131138383

    Patients

    Seq Age Sex Outcome Treatment
    1