BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ RELION® INSULIN SYRINGE

    MDR report key: 7268347 · Received February 13, 2018

    Report

    Report Number
    1920898-2018-00042
    Event Type
    Malfunction
    Date Received
    February 13, 2018
    Date of Event
    January 23, 2018
    Report Date
    April 23, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131138390
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: INVESTIGATION SUMMARY: 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. SEVERITY: S1; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER 7037606. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7037606. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THIS PRODUCT DOES NOT HAVE AN EXPIRATION DATE. SYRINGE ASSEMBLY - THERE WAS ONE (1) BATCH OF MATERIAL# 700009852 (SYRINGE 0.3ML ASM 31GA 6MM SM700153 SC) WHICH WAS CONSUMED INTO FINAL PRODUCT BATCH# 7037606. BATCH# 7080834 DATE(S) OF MANUFACTURE: 01APR2017 THRU 03APR2017. MACHINE(S) MANUFACTURED ON: JW, JX, JZ, NEEDLE LINES - THERE WERE SIX (6) BATCHES OF MATERIAL# 8365305 (NEEDLE SF ASM 31GA 6MM TW ORANGE) WHICH WERE CONSUMED INTO FINAL PRODUCT BATCH# 7037606. BATCH# 7076745 DATE(S) OF MANUFACTURE: 02APR2017 THRU 04APR2017 MACHINE(S) MANUFACTURED ON: NEEDLE LINE 6 BATCH# 7076743 DATE(S) OF MANUFACTURE: 01APR2017 THRU 04APR2017 MACHINE(S) MANUFACTURED ON: NEEDLE LINE 7 BATCH# 7076533 DATE(S) OF MANUFACTURE: 24MAR2017 THRU 26MAR2017 MACHINE(S) MANUFACTURED ON: NEEDLE LINE 7 BATCH# 7076532 DATE(S) OF MANUFACTURE: 22MAR2017 THRU 24MAR2017 MACHINE(S) MANUFACTURED ON: NEEDLE LINE 7 BATCH# 7065925 DATE(S) OF MANUFACTURE: 17MAR2017 THRU 19MAR2017 MACHINE(S) MANUFACTURED ON: NEEDLE LINE 6 BATCH# 7065924 DATE(S) OF MANUFACTURE: 16MAR2017 THRU 19MAR2017 MACHINE(S) MANUFACTURED ON: NEEDLE LINE 7 THERE WAS ONE (1) NOTIFICATION [200684932] 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. 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. H3 OTHER TEXT : SEE SECTION H.10.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 FOREIGN MATTER DESCRIBED AS ¿RUST¿ WAS SEEN ON THE END OF A BD¿ RELION® INSULIN SYRINGE WITH NEEDLE. THIS WAS OBSERVED BEFORE USE AND THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111989 BD¿ RELION® INSULIN SYRINGE INSULIN SYRINGE AND NEEDLE FMF BD MEDICAL - DIABETES CARE 7037606 00681131138390

    Patients

    Seq Age Sex Outcome Treatment
    1 Other