BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ ULTRA-FINE II¿ (SHORT) SELF-CONTAINED INSULIN SYRINGE

    MDR report key: 7443257 · Received April 19, 2018

    Report

    Report Number
    1920898-2018-00257
    Event Type
    Malfunction
    Date Received
    April 19, 2018
    Date of Event
    March 23, 2018
    Report Date
    May 22, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K955235
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TWO INVESTIGATIONS WERE CARRIED OUT. FIRST INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 1CC, 8MM, 30G SYRINGE IN AN OPEN POLY BAG FROM LOT # 7170638. CUSTOMER STATES THAT THE SCALE MARKINGS WERE MISSING ON A PORTION OF THE SYRINGE. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED PARTIALLY PRINTED SCALE MARKING ON THE BARREL. SAMPLE WAS FORWARDED TO MANUFACTURING (HOLDREGE) ON (B)(6)2018 FOR FURTHER REVIEW. SECOND INVESTIGATION SUMMARY: ON (B)(6)2018, HOLDREGE RECEIVED ONE (1) 1ML 8MM, 30G SYRINGE IN AN OPENED POLYBAG FROM BATCH# 7170638. ALL SAMPLES WERE DECONTAMINATED PER HSTR-17 PRIOR TO BEING EVALUATED. UPON EVALUATION BY QE AH, SIMILAR FINDINGS TO THOSE DOCUMENTED DURING INITIAL INVESTIGATION PERFORMED AT BD FRANKLIN LAKES WERE NOTED. PROBABLE ROOT CAUSE IS LIKELY TO BE THAT THE SCALE PRINT WAS SCRATCHED OFF DURING MOVEMENT OF THE SYRINGE THROUGH PACKAGING. GUIDE RAILS ARE USED TO TRANSPORT THE SYRINGE AND DURING EQUIPMENT ISSUES, SUCH AS JAMS, THE SYRINGE CAN SUSTAIN SOME DAMAGE, ESPECIALLY THE SCALE PRINTING. CAPA 162566 WAS INITIATED BY THE HOLDREGE PLANT TO ADDRESS PRINT RELATED DEFECTS AND THEIR ASSOCIATED ROOT CAUSE(S). BATCH# 7170638 WAS MANUFACTURED PRIOR TO INITIATION OF THIS CAPA. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7170638. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200702803, 200702903] NOTED 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 SCALE MARKING MISSING ON LOT # 7170638. 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.

    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 SCALE MARKING OF THE BD¿ ULTRA-FINE II¿ (SHORT) SELF-CONTAINED INSULIN SYRINGE WAS MISSING FROM A PORTION OF THE BARREL. FOUND BEFORE USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286053 BD¿ ULTRA-FINE II¿ (SHORT) SELF-CONTAINED INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7170638

    Patients

    Seq Age Sex Outcome Treatment
    1 Other