BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 10512689 · Received September 10, 2020

    Report

    Report Number
    1920898-2020-01187
    Event Type
    Malfunction
    Date Received
    September 10, 2020
    Date of Event
    August 20, 2020
    Report Date
    September 24, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908466035
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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: 9/17/2020. H.6. INVESTIGATION: CUSTOMER RETURNED (3) 1/2CC, 12.7MM, 30G SYRINGES IN OPEN POLY BAGS FROM LOT # 0041236. CUSTOMER STATES THAT THE NEEDLE HUB SEPARATED FROM THE SYRINGE AND STAYED INSIDE THE SYRINGE AND THE PLUNGER ROD IS DIFFICULT TO MOVE. ALL RETURNED SYRINGES WERE EXAMINED AND ONE SAMPLE WAS RETURNED WITH THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. BOTH REMAINING SAMPLES WERE TESTED TO DETERMINE THE SHIELD REMOVAL FORCES. BOTH REMOVAL FORCES FALL WITHIN SPECIFICATION. ALSO, ALL SAMPLES WERE TESTED AND ALL PLUNGER RODS WERE ABLE TO BE EXERCISED IN THE BARREL WITHOUT ANY OBSERVED DEFECTS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0041236. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200878621] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. - CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (HUB SEPARATES, SHIELD DIFFICULT TO REMOVE) - UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (PLUNGER DIFFICULT TO REMOVE) PROCESS SUMMARY: AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 0.5ML, 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. DHR, L2L DISPATCHES, AND LOGBOOK ENTRIES WERE LOOKED AT, NOTHING PERTAINING TO THIS DEFECT WAS FOUND. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. CAPA#1630423 WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ NEEDLE HUB SEPARATED FROM THE BD INSULIN SYRINGE DURING USE. ADDITIONALLY, IT WAS REPORTED THAT THE PLUNGER ROD WAS DIFFICULT TO MOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED NEEDLE SHIELD DIFFICULT TO REMOVE. NEEDLE HUB SEPARATED FROM SYRINGE AND STAYED INSIDE OF THE SHIELD. PLUNGER ROD DIFFICULT TO MOVE."

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ NEEDLE HUB SEPARATED FROM THE BD INSULIN SYRINGE DURING USE. ADDITIONALLY, IT WAS REPORTED THAT THE PLUNGER ROD WAS DIFFICULT TO MOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED NEEDLE SHIELD DIFFICULT TO REMOVE. NEEDLE HUB SEPARATED FROM SYRINGE AND STAYED INSIDE OF THE SHIELD. PLUNGER ROD DIFFICULT TO MOVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983770 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328466 0041236 00382908466035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other