BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 8428246 · Received March 18, 2019

    Report

    Report Number
    1920898-2019-00263
    Event Type
    Malfunction
    Date Received
    March 18, 2019
    Date of Event
    February 27, 2019
    Report Date
    April 5, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249107
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (8) LOOSE 0.3 ML 31G 6MM BD SYRINGES (USED). CONSUMER STATED THE HALF UNIT MARKINGS ARE NOT ON THE SOME OF THE SYRINGES FROM THIS BOX. ALL RETURNED SYRINGES WERE EXAMINED AND ALL 8 RETURNED SYRINGES EXHIBITED MISSING HALF UNIT MARKINGS BETWEEN THE 0 AND 5 UNIT MARKINGS, THUS CONFIRMING THE ALLEGED DEFECT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 6242615. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. 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. 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. VISUAL INSPECTION OF THE SYRINGES FOUND (4) SAMPLES WITH THE 2.5, 3.5 SCALE MARKING MISSING, (1) SAMPLE WITH THE 4.5 SCALE MARKING MISSING, (1) SAMPLE WITH THE 3.5 SCALE MARKING MISSING, (1) SAMPLE WITH THE 3.5, 4.5 SCALE MARKING MISSING, AND (1) SAMPLE WITH THE 2.5, 3.5, 4.5 SCALE MARKINGS MISSING. THE VERTICAL LINE AND SINGLE SCALE MARKINGS WERE PRESENT. THE PRECEDING SCALE LINE WOULD SHOW SIGNS OF FADING BEFORE THE FIRST SCALE MARK WOULD NOT BE PRESENT. THERE WAS NO VISIBLE DAMAGE TO THE BARRELS. PROBABLE ROOT CAUSE OF THE MISSING SCALE LINES IS FROM A DEFECTIVE OR DAMAGED INK PAD NOT ALLOWING A FULL PRESSING OF THE SCALE MARKINGS. COMPLAINT DATA WILL BE MONITORED FOR TRENDS RELATED TO THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "HALF" OF THE SCALE MARKINGS ON THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE WERE NOTICED TO BE MISSING DURING USE. AS REPORTED BY THE CUSTOMER, "FROM PHONE CALL ON (B)(6) 201916:44:46: RETURNED CALL. CONSUMER STATED THE HALF UNIT MARKINGS ARE NOT ON THE SOME OF THE SYRINGES FROM THIS BOX. SAMPLES AVAILABLE TO RETURN. CORRECTED "LAST NAME" SPELLING. CONSUMER IS EMAILING ADDRESS ACCORDING TO EMAIL RECEIVED, "HALF MARKS ON THE SYRINGES ARE MISSING".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 6242615. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. 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 "HALF" OF THE SCALE MARKINGS ON THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE WERE NOTICED TO BE MISSING DURING USE. AS REPORTED BY THE CUSTOMER, "FROM PHONE CALL ON (B)(6) 2019 16:44:46: RETURNED CALL. CONSUMER STATED THE HALF UNIT MARKINGS ARE NOT ON THE SOME OF THE SYRINGES FROM THIS BOX. SAMPLES AVAILABLE TO RETURN. CORRECTED "LAST NAME" SPELLING. CONSUMER IS EMAILING ADDRESS. ACCORDING TO EMAIL RECEIVED, "HALF MARKS ON THE SYRINGES ARE MISSING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220607 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 6242615 00382903249107

    Patients

    Seq Age Sex Outcome Treatment
    1 Other