BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    MDR report key: 7186351 · Received January 12, 2018

    Report

    Report Number
    1920898-2017-00436
    Event Type
    Malfunction
    Date Received
    January 12, 2018
    Date of Event
    December 19, 2017
    Report Date
    February 27, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908466035
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER 7121992. AS PER MANUFACTURING, A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7121992. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FOUR (4) NOTIFICATIONS [200696425, 200696494, 200696554, 200696523] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WERE TWO INVESTIGATIONS CARRIED OUT. (B)(4) INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 1/2CC, 12.7MM, 30G SYRINGE IN AN OPEN POLY BAG FROM LOT # 7121992. CUSTOMER STATES THAT THE SYRINGE HAD A HOLE IN IT. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A PIECE OF THE BARREL BROKEN OFF RANGING FROM THE 0-10 UNIT MARKINGS. (B)(4) INVESTIGATION SUMMARY: BD (B)(4) RECEIVED ONE (1) 0.5ML, 12.7MM, 30G SYRINGE IN AN OPENED POLYBAG FROM BATCH # 7121992. ALL SAMPLES WERE DECONTAMINATED PER HSTR-17 PRIOR TO BEING EVALUATED. UPON EVALUATION BY QE AH, SIMILAR FINDINGS WERE NOTED WITHIN THE SAMPLE AS THOSE DOCUMENTED DURING INITIAL INVESTIGATION PERFORMED AT BD (B)(4). PROBABLE ROOT CAUSE LIKELY TO BE A JAM IN THE PREP DIAL DURING ASSEMBLY. WHEN THIS OCCURS, DAMAGE TO THIS REGION OF THE SYRINGE IS MORE COMMON AND CAN RESULT IN THE DEFECT, AS SEEN WITH THIS COMPLAINT SAMPLE. THE END RESULT RENDERS THE DEVICE INOPERABLE BY THE END USER. PROBABLE ROOT CAUSE WAS NOTED TO BE THE BARREL LIKELY BEING BROKEN IN THE PREP DIAL PRIOR TO ASSEMBLY, WHICH ACCOUNTS FOR THE LACK OF DAMAGE TO THE NEEDLE ASSEMBLY. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. 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. BASED ON THE ABOVE, NO CAPA IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED A HOLE WAS FOUND IN THE SYRINGE PART OF A BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE, BEFORE USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31033 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE WITH NEEDLE FMF BD MEDICAL - DIABETES CARE 7121992 00382908466035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other