BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGE

    MDR report key: 10674281 · Received October 13, 2020

    Report

    Report Number
    1920898-2020-01396
    Event Type
    Malfunction
    Date Received
    October 13, 2020
    Date of Event
    October 2, 2020
    Report Date
    October 13, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311786
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) USA HAS BEEN USED AS A DEFAULT. (B)(4). INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. 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 (B)(4) NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WERE TWO (2) NOTIFICATIONS (B)(4) NOTED FOR CRACKED HUBS OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 11TH RELATED COMPLAINT FOR NEEDLE HUB SEPARATES ON LOT # 9231336. A REVIEW OF RISK MANAGEMENT DOCUMENT (B)(4) INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (INSULIN SYRINGE, NEEDLE HUB SEPARATES) WAS CAPTURED AND ADDRESSED. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 RELION® INSULIN SYRINGES HAD ISSUES WITH HUB SEPARATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED FOUND 2 SYRINGES FROM THIS BOX WHEN REMOVED NEEDLE SHIELD NEEDLE HUB GOES WITH SHIELD. HAS ONLY USED ABOUT 1/4 OF THE BOX SO FAR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134247 RELION INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328512 9231336 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1 Other