BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGE

    MDR report key: 9901302 · Received March 30, 2020

    Report

    Report Number
    2243072-2020-00529
    Event Type
    Malfunction
    Date Received
    March 30, 2020
    Date of Event
    March 10, 2020
    Report Date
    April 10, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    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 HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION RECEIVED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE NEEDLE SEPARATED FROM DEVICE AND STAYED IN VIAL WHEN DRAWING INSULIN WITH A RELION® INSULIN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOUND ANOTHER SYRINGE NEEDLE STAYED IN THE VIAL WHEN DRAWING UP INSULIN. D.1 MEDICAL DEVICE TYPE: FMF. D.3. MEDICAL DEVICE MANUFACTURER: BD MEDICAL ¿ DIABETES CARE ¿ HOLDREGE, NE / 68949. D.4 MEDICAL DEVICE CATALOG #: 328509. D.4. MEDICAL DEVICE LOT #: 9189582. D.4. MEDICAL DEVICE EXPIRATION DATE: N/A. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.2 MANUFACTURING LOCATION: BD MEDICAL ¿ DIABETES CARE ¿ HOLDREGE, NE / 68949. G.5. PMA / 510(K)#: K024112. H.4. DEVICE MANUFACTURE DATE: 2019-08-26. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (60) 31GX8MM, 0.5ML RELION INSULIN SYRINGES IN SEALED POLYBAGS FROM LOT: 9189582. CONSUMER REPORTED FOUND 2 SYRINGES WITHOUT A NEEDLE WHEN REMOVED THE NEEDLE SHIELD; CONSUMER REPORTED FROM THIS SAME PACKET FOUND ANOTHER SYRINGE NEEDLE STAYED IN VIAL WHEN DRAWING UP INSULIN. 30 OUT OF THE 60 RETURNED SYRINGES WERE SELECTED AND EXAMINED, AND NONE OF THE 30 SYRINGES WERE MISSING A CANNULA. A UV LIGHT WAS USED TO CONFIRM THE PRESENCE OF ADHESIVE ON ALL 30 TESTED SYRINGES. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. SINCE NO DEFECTS WERE OBSERVED ON THE TESTED SYRINGES THE ALLEGED ISSUES COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH#: 9189582. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. INVESTIGATION CONCLUSION: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE SEPARATED FROM DEVICE AND STAYED IN VIAL WHEN DRAWING INSULIN WITH A RELION® INSULIN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOUND ANOTHER SYRINGE NEEDLE STAYED IN THE VIAL WHEN DRAWING UP INSULIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE SEPARATED FROM DEVICE AND STAYED IN VIAL WHEN DRAWING INSULIN WITH AN UNSPECIFIED BD SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOUND ANOTHER SYRINGE NEEDLE STAYED IN THE VIAL WHEN DRAWING UP INSULIN.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE SEPARATED FROM DEVICE AND STAYED IN VIAL WHEN DRAWING INSULIN WITH AN UNSPECIFIED BD SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOUND ANOTHER SYRINGE NEEDLE STAYED IN THE VIAL WHEN DRAWING UP INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365379 RELION INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9189582

    Patients

    Seq Age Sex Outcome Treatment
    1 Other