BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ IV INSULIN SYRINGE

    MDR report key: 8197802 · Received December 26, 2018

    Report

    Report Number
    1920898-2018-00963
    Event Type
    Malfunction
    Date Received
    December 26, 2018
    Date of Event
    December 4, 2018
    Report Date
    April 16, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    30382903294245
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED A PHOTO OF A 1CC SYRINGE IN A BLISTER PACK. SEVERITY RANKING IS S1. UNABLE TO PERFORM COMPLAINT LOT HISTORY CHECK DUE TO UNKNOWN LOT NUMBER. UNABLE TO PERFORM DHR CHECK DUE TO UNKNOWN LOT NUMBER. INVESTIGATION CONCLUSION: THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A STRAND OF MATERIAL IN THE SEAL OF THE BLISTER PACK. ROOT CAUSE DESCRIPTION: IT IS DIFFICULT TO DETERMINE THE IDENTITY OF THIS MATERIAL AND ANY POSSIBLE ROOT CAUSES SOLELY FROM THE RETURNED PHOTO. RATIONALE: 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.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (1) BD 1CC, 12.7MM, 28G INSULIN SYRINGE IN A SEALED BLISTER PACK FROM LOT # 8113628. CUSTOMER STATES THAT A HAIR WAS LAMINATED IN THE SEAL OF THE PRODUCT. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A DARK STRAND OF MATERIAL IN THE SEAL OF THE BLISTER PACK. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY HAIR. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 8113628. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. PROBABLE ROOT CAUSE FOR THE FM IS FROM PASSING THROUGH THE VENT AND FALLING INTO THE OPEN TRAYS BEFORE BEING SEALED OR FROM A MAINTENANCE TECHNICIAN ENTERING THE MACHINE AND ALLOWING CONTAMINATION TO FALL INSIDE THE TRAY LOADERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "A HAIR WAS LAMINATED IN THE SEAL" OF THE BD MICRO-FINE¿ IV INSULIN SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "A HAIR WAS LAMINATED IN THE SEAL" OF THE BD MICRO-FINE¿ IV INSULIN SYRINGE.

    Additional Manufacturer Narrative · 1

    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 "A HAIR WAS LAMINATED IN THE SEAL" OF THE BD MICRO-FINE¿ IV INSULIN SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035722 BD MICRO-FINE¿ IV INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE UNKNOWN 30382903294245

    Patients

    Seq Age Sex Outcome Treatment
    1 Other