BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROFINE+ INSULIN SYRINGES

    MDR report key: 8557852 · Received April 26, 2019

    Report

    Report Number
    1920898-2019-00396
    Event Type
    Malfunction
    Date Received
    April 26, 2019
    Date of Event
    April 10, 2019
    Report Date
    April 22, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903248926
    PMA / PMN Number
    K941657
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8120891, MEDICAL DEVICE EXPIRATION DATE: 07/31/2023, DEVICE MANUFACTURE DATE: 04/30/2018. MEDICAL DEVICE LOT #: 7240991, MEDICAL DEVICE EXPIRATION DATE: 09/30/2022, DEVICE MANUFACTURE DATE: 2017-08-28. MEDICAL DEVICE LOT #: 8036912, MEDICAL DEVICE EXPIRATION DATE: 04/30/2023, DEVICE MANUFACTURE DATE: 02/05/2018. INVESTIGATION SUMMARY: LEVEL A INVESTIGATION COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR CANNULA DAMAGED/CRACKED AND CANNULA BROKEN ON LOT # 8120891, LOT # 7240991 AND LOT # 8036912. INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF 1/2CC SYRINGES. CUSTOMER STATES THAT THERE IS A CRACK IN THE CANNULA AND THE CANNULA IS BROKEN. ALL PHOTOS WERE EXAMINED AND CRACKED BARRELS AND A DAMAGED HUB WERE OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8120891. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7240991. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200720172, 200720171] NOTED FOR DAMAGED BARREL. THERE WERE FIVE (5) NOTIFICATIONS [200719948, 200720205, 200720038, 200719960, 200719959] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8036912. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200756423] NOTED FOR CRACKED HUBS. INVESTIGATION CONCLUSION: BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (CRACKED BARREL AND DAMAGED HUB) 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: POSSIBLE ROOT CAUSES FOR CRACKED BARREL AND DAMAGED HUB: DEFECT COULD HAVE OCCURRED AT THE PREP DIAL OF THE METRO ASSEMBLY MACHINE LOSS OF BACK PRESSURE ON THE IN-FEED RAIL MAY CAUSE THE BARREL TO BECOME PINCHED AT THE RAIL / PREP DIAL JUNCTION. THE TRIP GATE EYE SENSOR SHOULD DETECT LOW RAIL CONDITIONS AND ACTIVATE THE TRIP GATE TO PREVENT THE BARRELS FROM BEING LOADED INTO THE PREP DIAL AND POSSIBLY JAMMING AT THAT LOCATION. INFEED DIAL AT BARREL PRINTERS. LOSS OF BACK PRESSURE AT INFEED RAIL ALSO AT FORM FILL & SEAL. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD MICROFINE¿+ INSULIN SYRINGES HAD A CRACK IN THE CANNULA. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CRACK IN THE CANNULA / BROKEN CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349920 BD MICROFINE+ INSULIN SYRINGES INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE SEE H.10 00382903248926

    Patients

    Seq Age Sex Outcome Treatment
    1 Other