BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 30GA 8MM

    MDR report key: 8816427 · Received July 23, 2019

    Report

    Report Number
    1920898-2019-00687
    Event Type
    Malfunction
    Date Received
    July 23, 2019
    Date of Event
    July 2, 2019
    Report Date
    August 30, 2019
    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
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) LOOSE 30G X 8MM, 0.3ML BD INSULIN SYRINGE. IT WAS REPORTED THAT THE NEEDLE PIERCED THRU THE SHIELD; THE NEEDLE STUNG A FINGER OF THE NURSE BEFORE USE. THE RETURNED SAMPLE WAS EXAMINED, AND IT WAS OBSERVED THAT THE CANNULA WAS THROUGH THE SHIELD. UNABLE TO PERFORM DHR REVIEW 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. AS PER INVESTIGATION COMPLETED BY MANUFACTURING UNDER INVESTIGATION CHILD 1113832, "ON 19TH AUGUST 2019, HOLDREGE RECEIVED ONE 0.3CC 30G 8MM BD INSULIN SYRINGE OF BATCH# : N/A; MATERIAL NUMBER: 326638 IN A TRAY. ALL SAMPLES WERE DECONTAMINATED PER HSTR-17 AND HQA-68 PRIOR TO BEING EVALUATED. AFTER VISUAL INSPECTION OF THE SAMPLE, WE WOULD CONFIRM THAT IT IS CANNULA THROUGH SHIELD AND HAPPENED AFTER GETTING CANNULATED, PASSED THE PIM INSPECTION FOR CANNULA ANGULARITY. IT MUST HAVE HAPPENED DURING THE PROCESS OF SHIELDING. PROCESS: ¿RACKS LOADED WITH HUBS TRAVEL DOWN A CONVEYOR TOWARDS THE CANNULATOR. ¿THEY APPROACH THE CANNULATOR TURNING HORIZONTALLY IN ORDER TO RECEIVE CANNULA. ¿RACKS PASS UNDER MARS MAGNET STRAIGHTENING THE CANNULA IN THE HUBS. THE RACK PASSES UNDER TWO ULTRAVIOLET LAMPS, WHICH CAUSES THE ADHESIVE TO CURE. ¿THEN THE RACKS GO TO THE SHIELDER WITH THE USE OF LINEAR MOTION. THE RACK LOCATER POSITIONS THE RACKS WHILE GETTING SHIELDED. ¿THE PARTS ARE FIRST INSPECTED WITH AN ANGULARITY CAMERA, AND IF THE ANGLE OF THE CANNULA IS TOO GREAT OR THERE IS NOTHING ON THAT PIN, THE PART IS NOT SHIELDED. ¿THE FINISHED PRODUCT PICK AND PLACE HEAD WON¿T PICK IT UP IN THE GRIPPER AS IT IS GRIPPING THE SHIELD FOR PICK UP. INVESTIGATION: BATCH NUMBER: N/A ROOT CAUSE: ROOT CAUSE CANNOT BE DETERMINED AS THE BATCH NUMBER IS NOT AVAILABLE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE WAS FOUND THROUGH SHIELD BEFORE USE WITH A SYRINGE 0.3ML 30GA 8MM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE NEEDLE PIERCED THRU THE SHIELD. THE NEEDLE STUNG A FINGER OF THE NURSE BEFORE USE."

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE WAS FOUND THROUGH SHIELD BEFORE USE WITH A SYRINGE 0.3ML 30GA 8MM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. "THE NEEDLE PIERCED THRU THE SHIELD. THE NEEDLE STUNG A FINGER OF THE NURSE BEFORE USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609408 SYRINGE 0.3ML 30GA 8MM SYRINGE FMF BD MEDICAL - DIABETES CARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other