BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE

    MDR report key: 7804664 · Received August 22, 2018

    Report

    Report Number
    1920898-2018-00648
    Event Type
    Malfunction
    Date Received
    August 22, 2018
    Date of Event
    August 3, 2018
    Report Date
    September 10, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903282784
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER; DEVICE SINGLE USE?: NO; DEVICE RETURNED TO MANUFACTURE: NO. INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) LOOSE 1CC SYRINGE. CUSTOMER STATES THAT MEDICATION LEAKED OUT BECAUSE THE BARREL WAS CRACKED. THE RETURNED SYRINGE WAS EXAMINED AND IT EXHIBITED A CRACKED BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7121823. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200695613] 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 LEAKAGE AND BARREL DAMAGED/CRACKED ON LOT # 7121823. SAMPLE WAS FORWARDED TO MANUFACTURING (HOLDREGE) ON 31 AUGUST 2018 FOR FURTHER REVIEW. ON 11SEP2018, HOLDREGE RECEIVED ONE (1) 1ML, 12.7MM SYRINGE FROM REPORTED BATCH# 7121823. ALL SAMPLES ARE 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, GIVEN THE SEVERITY OF THE DAMAGE TO THE SYRINGE, IS LIKELY TO BE A JAW JAM ON THE FFS (FORM FILL & SEAL) EQUIPMENT. WHEN THIS OCCURS, ANY PORTION OR COMPONENT OF THE SYRINGE MAY BE IMPACTED, AND THE RESULTING DEVICE IS GENERALLY RENDERED INOPERABLE, SUCH AS IS NOTED WITH THIS RETURNED SAMPLE. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE - CRACKED BARREL. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. 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. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE HAD A CRACKED SYRINGE BARREL THAT LED TO A LEAK. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE HAD A CRACKED SYRINGE BARREL THAT LED TO A LEAK. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645212 BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7121823 00382903282784

    Patients

    Seq Age Sex Outcome Treatment
    1 Other