BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE

    MDR report key: 9667285 · Received February 4, 2020

    Report

    Report Number
    1920898-2020-00074
    Event Type
    Malfunction
    Date Received
    February 4, 2020
    Date of Event
    January 15, 2020
    Report Date
    February 19, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908438032
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED (40) 31GX8MM, 0.3ML BD INSULIN SYRINGES FROM LOT 9161986 (20 FROM OPENED POLYBAGS AND 20 FROM UNUSED/SEALED POLYBAGS). CONSUMER REPORTED SYRINGES ARE STICKING WHEN FULL WITH WHATEVER THEY HAVE IN THEM. 30 OUT OF THE 40 RETURNED SYRINGES WERE EXAMINED, THEN TESTED FOR PLUNGER ROD MOVEMENT AND FLOW: ALL 30 TESTED SYRINGES HAD PLUNGERS THAT WERE ABLE TO MOVE AND DRAW AND EXPEL PROPERLY. SINCE NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED THE ALLEGED ISSUE COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9161986. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. INVESTIGATION CONCLUSION: BD WAS NOT 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. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE IS GETTING STUCK DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 328438 BATCH NO.: UNKNOWN. IT WAS REPORTED THAT THE SYRINGES ARE STICKING WHEN FULL. VERBATIM: I HAVE A CUSTOMER THAT IS CLAIMING THAT HER SYRINGES ARE STICKING WHEN FULL WITH WHATEVER THEY HAVE IN THEM. I TOOK DOWN THE INFORMATION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). 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 INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE IS GETTING STUCK DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 328438 BATCH NO.: UNKNOWN. IT WAS REPORTED THAT THE SYRINGES ARE STICKING WHEN FULL. VERBATIM: I HAVE A CUSTOMER THAT IS CLAIMING THAT HER SYRINGES ARE STICKING WHEN FULL WITH WHATEVER THEY HAVE IN THEM. I TOOK DOWN THE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132262 BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328438 9161986 00382908438032

    Patients

    Seq Age Sex Outcome Treatment
    1 Other