BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE

    MDR report key: 8019240 · Received October 30, 2018

    Report

    Report Number
    1920898-2018-00800
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Date of Event
    October 10, 2018
    Report Date
    November 30, 2018
    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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 1/2CC, 8MM, 30G SYRINGE IN AN OPEN POLY BAG FROM LOT # 7100885. CUSTOMER STATES THAT THE PLUNGER IS BROKEN. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A BROKEN THUMB PRESS ON THE PLUNGER ROD. SAMPLE WAS FORWARDED TO MANUFACTURING (HOLDREGE) ON 09NOV2018 FOR FURTHER REVIEW. ON 12NOV2018, HOLDREGE RECEIVED ONE (1) 0.5ML. 8MM, 30G SYRINGE IN AN OPENED POLYBAG FROM BATCH# 7100885. ALL SAMPLES ARE DECONTAMINATED PER HSTR-17 AND HQA-68 PRIOR TO BEING EVALUATED. UPON EVALUATION BY QE, SIMILAR FINDINGS TO THOSE DOCUMENTED DURING INITIAL INVESTIGATION PERFORMED AT BD FRANKLIN LAKES WERE NOTED. THE RETURNED SAMPLE WAS VISUALLY INSPECTED AND ADDITIONALLY NOTED THAT BOTH THE FLANGE WAS BOWED AND THE APERTURE IN-WHICH THE PLUNGER ROD IS ASSEMBLED APPEARED TO BE SQUISHED, CAUSING IT TO BE OUT-OF-ROUND. PROBABLE ROOT CAUSE FOR THIS DEFECT IS LIKELY TO BE A JAW JAM ON THE FFS (FORM FILL & SEAL) EQUIPMENT, WHICH CAN INVOLVE THE SYRINGE AND/OR ANY COMPONENTS IN THE EVENT. THOSE PORTIONS OF THE SYRINGE THAT ARE INVOLVED IN THE JAM CAN EXHIBIT VARYING DEGREES OF DAMAGE, SUCH AS IS NOTED AFTER INSPECTION OF THE RETURNED SAMPLE. GENERALLY, THE RESULT IS AN INOPERABLE DEVICE BY THE END USER. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7100885. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE EIGHTEEN (18) NOTIFICATIONS THAT DID NOT PERTAIN TO THE COMPLAINT. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR BROKEN PLUNGER ON LOT # 7100885. BASED ON THE SAMPLES / 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ INSULIN SYRINGE PLUNGER WAS BROKEN. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    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 BD ULTRA-FINE¿ INSULIN SYRINGE PLUNGER WAS BROKEN. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861584 BD ULTRA-FINE¿ INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7100885

    Patients

    Seq Age Sex Outcome Treatment
    1 Other