BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE

    MDR report key: 7679514 · Received July 11, 2018

    Report

    Report Number
    1920898-2018-00500
    Event Type
    Malfunction
    Date Received
    July 11, 2018
    Date of Event
    June 18, 2018
    Report Date
    August 14, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903294169
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED TO FRANKLIN LAKES (1) 1CC, 8MM, 31G SYRINGE IN AN OPEN POLY BAG FROM LOT # 7241532. CUSTOMER STATES THAT INSULIN LEAKS AROUND THE NEEDLE HUB. THE RETURNED SYRINGE WAS TESTED AND WAS NOT ABLE TO DRAW PROPERLY. THE SAMPLE WAS THEN EXAMINED UNDER THE MICROSCOPE AND EXHIBITED ADHESIVE RUNOFF ONTO THE BARREL. THIS COULD CAUSE LEAKAGE AS THERE IS INSUFFICIENT ADHESIVE IN THE HUB. SAMPLE WERE FORWARDED TO MANUFACTURING (HOLDREGE) ON 20JUL2018 FOR FURTHER REVIEW. ON 26JUL2018, HOLDREGE RECEIVED ONE (1) 1ML, 8MM, 31G SYRINGE IN AN OPENED POLYBAG FROM BATCH # 7241532. 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. THE RETURNED SAMPLE WAS VISUALIZED UNDER ULTRAVIOLET LIGHTING AND CONFIRMED THE PRESENCE OF ADHESIVE ALONG THE EXTERIOR SIDE AND BARREL TIP SIDE WELL. TRACE ADHESIVE WAS NOTED WITHIN THE BARREL TIP ITSELF. PROBABLE ROOT CAUSE IS A MISALIGNMENT OF THE ADHESIVE NOZZLE DURING APPLICATION ON THE PILS (POINT INSPECT LUBE SHIELD) EQUIPMENT. WHEN THIS OCCURS, THERE IS A GREATLY INCREASED CHANCE OF FINDING ADHESIVE APPLIED TO UNINTENDED PORTIONS OF THE BARREL TIP AND BARREL TIP SIDE WELL, AS IS NOTED WITHIN THE RETURNED SAMPLE. CAPA 226773 WAS INITIATED BY THE HOLDREGE PLANT TO ADDRESS 1ML CUSTOMER COMPLAINTS AND THEIR ASSOCIATED ROOT CAUSE(S). BATCH# 7241532 WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF ANY CORRECTIVE/PREVENTIVE ACTIONS ASSOCIATED WITH THIS CAPA. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7241532. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS [200712892, 200712495, 200712933] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 4TH RELATED COMPLAINT FOR LEAKAGE ON LOT # 7241532. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: - CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (ADHESIVE RUNOFF). 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 · 0

    CORRECTION: 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: SEX: MALE. EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA-FINE¿ INSULIN SYRINGE HAD "INSULIN LEAK AROUND THE NEEDLE HUB DURING INJECTION". NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA-FINE¿ INSULIN SYRINGE HAD "INSULIN LEAK AROUND THE NEEDLE HUB DURING INJECTION". NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: 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 BD ULTRA-FINE¿ INSULIN SYRINGE HAD "INSULIN LEAK AROUND THE NEEDLE HUB DURING INJECTION". NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522373 BD ULTRA-FINE¿ INSULIN SYRINGE SYRINGE FMF BD MEDICAL - DIABETES CARE 7241532 00382903294169

    Patients

    Seq Age Sex Outcome Treatment
    1 Other