BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE

    MDR report key: 7175765 · Received January 9, 2018

    Report

    Report Number
    1920898-2017-00416
    Event Type
    Malfunction
    Date Received
    January 9, 2018
    Date of Event
    December 15, 2017
    Report Date
    February 27, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, A NO SAMPLE INVESTIGATION AND DEVICE HISTORY RECORD REVIEW WILL BE COMPLETED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: SEVERITY: OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR SCALE PRINT DEFECTIVE, FOREIGN MATTER, CRUSHED PLUNGER CAP AND BROKEN THUMB PRESS ON LOT # 7023727. AS PER MANUFACTURING, A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7023727. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO NOTIFICATIONS (B)(4) NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. TWO INVESTIGATIONS WERE CARRIED OUT. FRANKLIN LAKES INVESTIGATION SUMMARY: CUSTOMER RETURNED 1/2CC, 8MM SYRINGE AND 1CC, 8MM SYRINGE IN OPEN POLY BAGS FOR 1/2CC, 8MM, 31G SYRINGES FROM LOT # 7023727. CUSTOMER STATES THAT THE BARREL IS DISTORTED AND FLUID IS IN THE BARREL. BOTH RETURNED SYRINGES WERE EXAMINED AND THE 1/2CC SYRINGE EXHIBITED A CRUSHED PLUNGER CAP RESULTING IN A BROKEN THUMB PRESS AND DEFORMED FLANGE ON THE BARREL. THE 1CC SYRINGE EXHIBITED A SMALL AMOUNT OF CLEAR LIQUID INSIDE THE BARREL. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SYRINGE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SUGGESTS THAT THIS MATERIAL HAS COMPONENTS SIMILAR TO THOSE OF INSULIN. INSULIN WOULD NOT HAVE BEEN ACQUIRED DURING THE MANUFACTURING PROCESS. HOLDREGE INVESTIGATION SUMMARY: RECEIVED ONE 0.5ML, 8MM, 31G SYRINGE IN OPENED POLYBAGS FROM BATCH # 7023727. ADDITIONALLY, ONE 1ML SYRINGE FROM AN UNKNOWN CATALOG/BATCH WAS RECEIVED. ALL SAMPLES WERE DECONTAMINATED PER HSTR-17 PRIOR TO BEING EVALUATED. UPON EVALUATION BY (B)(4), SIMILAR FINDINGS AS NOTED DURING INITIAL INVESTIGATION IN FRANKLIN LAKES WERE OBSERVED. PROBABLE ROOT CAUSE FOR DEFECTS NOTED IN 0.5ML SAMPLE LIKELY TO BE DUE TO A JAW JAM ON THE FORM FILL & SEAL (FF&S). DURING SEALING OF THE POLYBAGS, IF A JAW JAM OCCURS, ANY PORTION OF A SYRINGE MAY BECOME DAMAGED, TO A WIDE DEGREE OF VARIABILITY, DEPENDING ON WHERE AND FOR HOW LONG IT IS CAUGHT IN THE JAM. THE DEFECTIVE SYRINGE/COMPONENT MAY MAKE IT THROUGH THE PACKAGING PROCESS AND ON TO THE END USER. GENERALLY THESE DEFECTS RENDER THE DEVICE UN-USABLE BY THE CONSUMER. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF CRUSHED PLUNGER CAP, BROKEN THUMB PRESS, AND DAMAGED FLANGE. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF FOREIGN MATTER AS A MANUFACTURING DEFECT AS INSULIN WOULD NOT HAVE BEEN ACQUIRED DURING THE MANUFACTURING PROCESS 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 · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN A BD ULTRA-FINE¿ INSULIN SYRINGE BEFORE USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20048 BD ULTRA-FINE¿ INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7023727

    Patients

    Seq Age Sex Outcome Treatment
    1 Other