BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGE

    MDR report key: 10714641 · Received October 21, 2020

    Report

    Report Number
    1920898-2020-01441
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    September 27, 2020
    Report Date
    October 30, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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: 2020-10-23 H6: INVESTIGATION SUMMARY CUSTOMER RETURNED ONE (1) 0.3ML INSULIN SYRINGE FROM LOT 9231336. CONSUMER REPORTED NEEDLE HUB SEPARATED WHEN REMOVING SHIELD. THE RETURNED SYRINGE WAS EXAMINED, AND IT NO NEEDLE HUB/SHIELD ASSEMBLY SEPARATION WAS OBSERVED. THE SYRINGE WAS TESTED TO DETERMINE THE SHIELD REMOVAL FORCE (SPECS: SHIELD REMOVAL FORCE FOR 0.3 ML SYRINGE AFTER STERILIZATION IS 0.85 TO 5.95LBS) AND THE FOLLOWING WAS OBSERVED: SAMPLE NUMBER SHIELD REMOVAL FORCE (LBS) SAMPLE 1 3.04 THE SYRINGE TESTED WITHIN SHIELD PULL SPECIFICATION, AND NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. SINCE NO DEFECTS WERE OBSERVED, THE ALLEGED ISSUE COULD NOT BE CONFIRMED. 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 (1) NOTIFICATION [200872529] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WERE TWO (2) NOTIFICATIONS [200872129, 200872284] NOTED FOR CRACKED HUBS. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RELION® INSULIN SYRINGE EXPERIENCED HUB SEPARATION FROM DEVICE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT 1 OF 2 RELION PET OWNER REPORTED NEEDLE HUB SEPARATED WHEN REMOVING SHIELD 2 SYRINGES AFFECTED LOT: 9231336 CATALOG: 3/10, 31G, 8MM DATE OF EVENT: (B)(6) 2020

    Additional Manufacturer Narrative · 1

    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 DEVICE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT 1 OF 2. RELION PET OWNER REPORTED NEEDLE HUB SEPARATED WHEN REMOVING SHIELD 2 SYRINGES AFFECTED. LOT: 9231336. CATALOG: 3/10, 31G, 8MM. DATE OF EVENT: (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180596 RELION INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9231336

    Patients

    Seq Age Sex Outcome Treatment
    1