BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION¿ INSULIN SYRINGE

    MDR report key: 8175072 · Received December 18, 2018

    Report

    Report Number
    1920898-2018-00957
    Event Type
    Malfunction
    Date Received
    December 18, 2018
    Date of Event
    December 4, 2018
    Report Date
    January 21, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311762
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (10) 1/2CC, 8MM, 31G RELION SYRINGES IN AN OPEN POLY BAG FROM LOT # 8121617. CUSTOMER STATES THAT THE SYRINGES HAVE BROKEN CAPS AND THUMB PRESSES. SEVERITY RANKING IS S1. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR PLUNGER CAP BROKEN AND THUMB PRESS BROKEN ON LOT # 8121617. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8121617. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FIVE (5) NOTIFICATIONS THAT DID NOT PERTAIN TO THE COMPLAINT. INVESTIGATION CONCLUSION: ALL RETURNED SYRINGES WERE EXAMINED AND ONE SAMPLE EXHIBITED A BROKEN THUMB PRESS WITH THE PLUNGER CAP CRUSHED AND CAUGHT IN THE SEAL OF THE POLY BAG. SAMPLES WERE FORWARDED TO MANUFACTURING (HOLDREGE) ON 04JAN2019 FOR FURTHER REVIEW. ON 04 JAN 2019, HOLDREGE RECEIVED TEN (10) 0.5ML, 8MM, 31G RELION SYRINGES IN AN OPENED POLYBAG FROM BATCH# 8121617. ALL SAMPLES WERE DECONTAMINATED PER HSTR-17 AND HQA-68 PRIOR TO BEING EVALUATED. UPON EVALUATION BY QE AH, SIMILAR FINDINGS TO THOSE DOCUMENTED DURING INITIAL INVESTIGATION PERFORMED AT BD FRANKLIN LAKES WERE NOTED. ROOT CAUSE DESCRIPTION: GIVEN THE DAMAGE TO THE DEVICE AND COMPONENTS, AS WELL AS THE POLYBAG, ROOT CAUSE IS LIKELY TO BE A JAW JAM ON THE FFS (FORM FILL & SEAL) EQUIPMENT DURING PACKAGING OF THE SYRINGES. WHEN THIS TYPE OF EVENT OCCURS, ANY PORTION OF THE SYRINGE/COMPONENTS MAY BE INVOLVED IN THE JAM AND EXHIBIT VARYING DEGREES OF DAMAGE, SUCH AS THAT NOTED WITHIN THE RETURNED SAMPLES. RATIONALE: AS A PART OF BD'S CULTURE OF CONTINUOUS IMPROVEMENT, EVALUATION OF THE PRODUCTION EQUIPMENT AND PROCESSES IS CURRENTLY UNDERWAY TO IMPROVE THE QUALITY OF OUR PACKAGING OPERATIONS, INCLUDING REDUCING INCIDENTS AS NOTED WITHIN THIS COMPLAINT RECORD. BASED ON THE ABOVE, NO CAPA IS REQUIRED AT THIS TIME. 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.

    Additional Manufacturer Narrative · 0

    NO SAMPLES (INCLUDING PHOTOS) 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# 8121617. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FIVE (5) NOTIFICATIONS [200748621, 200749661, 200748819, 200748923, 200748704] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES/PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLUNGER CAPS AND THUMB PRESS WERE BROKEN ON THE RELION¿ INSULIN SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLUNGER CAPS AND THUMB PRESS WERE BROKEN ON THE RELION INSULIN SYRINGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLUNGER CAPS AND THUMB PRESS WERE BROKEN ON THE RELION¿ INSULIN SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016945 RELION¿ INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8121617 00681131311762

    Patients

    Seq Age Sex Outcome Treatment
    1 Other