BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 10014794 · Received April 30, 2020

    Report

    Report Number
    1920898-2020-00444
    Event Type
    Malfunction
    Date Received
    April 30, 2020
    Date of Event
    April 10, 2020
    Report Date
    May 27, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249107
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 5/13/2020. H.6. INVESTIGATION: CUSTOMER RETURNED ONE (1) 0.3ML BD INSULIN SYRINGE FROM AN OPEN POLYBAG FROM LOT 9210500. CONSUMER REPORTED NEEDLE SHIELDS FIT TIGHT; 2 OF THESE SYRINGE NEEDLE HUB REMOVED WITH SHIELD. THE RETURNED SYRINGE WAS EXAMINED, AND IT WAS OBSERVED THAT THE NEEDLE HUB/SHIELD ASSEMBLY WAS SEPARATED FROM THE SYRINGE BARREL; NO DAMAGE TO THE BARREL TIP WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 9210500 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200840071] NOTED FOR OUT OF SPEC SHIELD PULL. PROCESS SUMMARY: AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 3/10CC, SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER, NEEDLE ASSEMBLY & CAP) AND ASSEMBLES THESE COMPONENTS. THIS MACHINE CONSISTS OF A BARREL CLEANING DIAL, LUBRICATION DIAL, PLUNGER/STOPPER ASSEMBLY DIAL, SYRINGE ASSEMBLY DIAL, AND VARIOUS INSPECTIONS AND TRANSFER DIALS. ROOT CAUSE: L2L DISPATCH #75252 WAS FOR RAISED HUBS. THE GUIDE WAS OUT OF ADJUSTMENT. CORRECTIVE ACTION: THE GUIDE WAS ADJUSTED. CAPA#1122103 WAS INITIATED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY : NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF 8 MAY 2020 THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 9210500 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200840071] NOTED FOR OUT OF SPEC SHIELD PULL INVESTIGATION CONCLUSION : BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. 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 AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HUB SEPARATED FROM THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE WHEN THE "TIGHT" SHIELD WAS REMOVED DURING USE. THIS OCCURRED ON 2 SEPARATE OCCASIONS, BUT THE DATES ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED NEEDLE SHIELDS FIT TIGHT. 2 OF THESE SYRINGE NEEDLE HUB REMOVED WITH SHIELD".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HUB SEPARATED FROM THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE WHEN THE "TIGHT" SHIELD WAS REMOVED DURING USE. THIS OCCURRED ON 2 SEPARATE OCCASIONS, BUT THE DATES ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED NEEDLE SHIELDS FIT TIGHT. 2 OF THESE SYRINGE NEEDLE HUB REMOVED WITH SHIELD"

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 HUB SEPARATED FROM THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE WHEN THE "TIGHT" SHIELD WAS REMOVED DURING USE. THIS OCCURRED ON 2 SEPARATE OCCASIONS, BUT THE DATES ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED NEEDLE SHIELDS FIT TIGHT. 2 OF THESE SYRINGE NEEDLE HUB REMOVED WITH SHIELD"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476292 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324910 9210500 00382903249107

    Patients

    Seq Age Sex Outcome Treatment
    1 Other