BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE

    MDR report key: 7478273 · Received May 1, 2018

    Report

    Report Number
    1920898-2018-00302
    Event Type
    Malfunction
    Date Received
    May 1, 2018
    Date of Event
    April 20, 2018
    Report Date
    June 11, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TWO INVESTIGATIONS WERE CARRIED OUT. FIRST INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 3/10CC, 6MM, 31G SYRINGE IN AN OPEN POLY BAG FROM LOT # 7030961. CUSTOMER STATES THAT THERE IS A BLACK RESIDUE IN THE MIDDLE OF THE NEEDLE. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED SOME DARK MATERIAL ON THE SURFACE OF THE CANNULA SHAFT. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SUGGESTS THAT THIS MATERIAL HAS COMPONENTS SIMILAR TO THOSE OF ADHESIVE. SAMPLE WERE FORWARDED TO MANUFACTURING ((B)(4)) ON 18MAY2018 FOR FURTHER REVIEW. SECOND INVESTIGATION SUMMARY: ON 22MAY2018, (B)(4) RECEIVED ONE (1) 0.3ML, 6MM, 31 SYRINGE IN OPENED POLYBAG FROM BATCH # 7030961. ALL SAMPLES WERE DECONTAMINATED PER HSTR-17 PRIOR TO BEING EVALUATED. UPON EVALUATION BY QE AH, SIMILAR FINDINGS TO THOSE DOCUMENTED DURING INITIAL INVESTIGATION PERFORMED AT BD (B)(4) WERE NOTED. PER FTIR ANALYSIS, FOREIGN MATERIAL APPEARS TO BE THAT OF ADHESIVE. PROBABLE ROOT CAUSE IS EITHER THE MISALIGNMENT OF THE ADHESIVE NOZZLE DURING APPLICATION OR POTENTIALLY A MISSED CANNULATION ON THE PART PRIOR TO THIS SAMPLE'S HUB (AS IDENTIFIED AS A ROOT CAUSE IN THE BELOW REFERENCED CAPA). (B)(4) WAS INITIATED BY THE (B)(4) PLANT TO ADDRESS SHIELD DIFFICULT TO REMOVE/ADHESIVE RUN-OVER AND THEIR ASSOCIATED ROOT CAUSE(S). BATCH# 7030961 WAS MANUFACTURED PRIOR TO INITIATION OF THIS CAPA. NO ADDITIONAL ACTIONS AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7030961. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS [200683822, 200683853, 200683642] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 2ND RELATED COMPLAINT FOR FOREIGN MATTER ON NEEDLE ON LOT # 7030961. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. PROBABLE ROOT CAUSE DETERMINED TO BE MISALIGNMENT DURING APPLICATION OF ADHESIVE ON THE NEEDLE LINES. WHEN THIS OCCURS, ADHESIVE RUNOVER ONTO THE HUB OR POSSIBLE THE CANNULA MAY OCCUR. ADDITIONALLY, ADHESIVE MAY BE INACCURATELY APPLIED TO THE RUBBERIZED PULL WHEEL ON THE LINE, WHICH CAN ADDITIONALLY TRANSFER ADHESIVE TO THE CANNULA DURING ROUTINE USE. 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 · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). 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 WITH THE USE OF THE BD ULTRA-FINE¿ INSULIN SYRINGE THERE WAS AN ISSUE WITH FOREIGN MATTER. IT WAS STATED ¿IN THE MIDDLE OF NEEDLE THERE IS A BLACK RESIDUE, AS IF THE NEEDLE HAVE HAD CONTACT WITH FIRE.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318352 BD ULTRA-FINE¿ INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7030961

    Patients

    Seq Age Sex Outcome Treatment
    1 Other