BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE II INSULIN SYRINGE

    MDR report key: 9378024 · Received November 26, 2019

    Report

    Report Number
    1920898-2019-01338
    Event Type
    Malfunction
    Date Received
    November 26, 2019
    Date of Event
    November 11, 2019
    Report Date
    January 2, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) LOOSE 1CC, 8MM SYRINGE. CUSTOMER STATES THAT THE BARREL IS BROKEN, LUBRICANT IS STUCK INSIDE THE BARREL AND THEY CAN¿T PULL AND PUSH THE PLUNGER. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A BROKEN BARREL FROM THE 70 UNIT MARKING TO THE FLANGE. THE SAMPLE ALSO EXHIBITED CLEAR DROPLETS OF MATERIAL IN THE BARREL. THE SAMPLE WAS TESTED AND THE PLUNGER ROD WAS ABLE TO BE EXERCISED IN THE BARREL WITHOUT ANY OBSERVED DEFECTS. A SMALL PORTION OF THE CLEAR DROPLETS OF MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY INSULIN, WHICH WOULD NOT HAVE BEEN ACQUIRED DURING THE MANUFACTURING PROCESS. UNABLE TO PERFORM DHR CHECK FOR BROKEN BARREL, FOREIGN MATTER IN BARREL AND PLUNGER DIFFICULT/UNABLE TO OPERATE DUE TO UNKNOWN LOT NUMBER. 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 (BROKEN BARREL). UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (FM- INSULIN WOULD NOT HAVE BEEN ACQUIRED DURING THE MANUFACTURING PROCESS, PLUNGER DIFFICULT TO OPERATE- NOT OBSERVED). AS PER INVESTIGATION COMPLETED BY MANUFACTURING, "ON 19DEC2019, HOLDREGE RECEIVED PHOTOS OF 1.0ML, 8MM SYRINGE FROM LOT #9028863. VISUAL INSPECTION OF THE PHOTO FOUND DAMAGE TO THE BARREL NEAR THE CAP COLLAR FLANGE. THE MATERIAL OF THE SYRINGE BARREL WAS CRACKED AND SEPARATED FROM THE "70" UNIT MARK TO JUST SHORT OF THE FLANGE. UNABLE TO REVIEW QUALITY NOTIFICATIONS AND MAINTENANCE DISPATCHES DUE TO UNKNOWN LOT NUMBER. UNABLE TO DETERMINE ROOT CAUSE OF THE DAMAGE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORT CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED AND TREND ON REPORTS MONITORED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA-FINE¿ II INSULIN SYRINGE BARREL WAS BROKEN. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROKEN BARREL AND LUBRICANT STUCK INSIDE THE BARREL. CAN'T PULL AND PUSH THE PLUNGER.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ULTRA-FINE¿ II INSULIN SYRINGE BARREL WAS BROKEN. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROKEN BARREL AND LUBRICANT STUCK INSIDE THE BARREL. CAN'T PULL AND PUSH THE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174724 BD ULTRA-FINE II INSULIN SYRINGE SYRINGE FMF BD MEDICAL - DIABETES CARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other