BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE

    MDR report key: 12601779 · Received October 8, 2021

    Report

    Report Number
    1920898-2021-01060
    Event Type
    Malfunction
    Date Received
    October 8, 2021
    Date of Event
    September 10, 2021
    Report Date
    October 21, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249107
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 10/4/2021. H.6. INVESTIGATION: CUSTOMER RETURNED (8) 3/10CC, 6MM, 31G SYRINGES IN AN OPEN POLY BAG FROM LOT # 0189393. CUSTOMER STATES THAT THERE WAS LIQUID IN THE SYRINGES. ALL RETURNED SYRINGES WERE EXAMINED AND NO SAMPLES EXHIBITED VISIBLE LIQUID IN THE BARREL. HOWEVER, ONE SAMPLE WAS TESTED AND EXHIBITED A CLEAR DROPLET OF MATERIAL COMING OUT THE CANNULA WHEN THE PLUNGER ROD WAS FULLY DEPRESSED. NONE OF THE OTHER RETURNED SYRINGES WERE TESTED. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY SILICONE. CUSTOMER RETURNED (2) 3/10CC, 6MM, 31G SYRINGES IN AN OPEN POLY BAG FROM LOT # 0279520. CUSTOMER STATES THAT THERE WAS LIQUID IN THE SYRINGES. BOTH RETURNED SYRINGES WERE EXAMINED AND BOTH SAMPLES EXHIBITED VISIBLE LIQUID IN THE BARREL. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY SILICONE. CUSTOMER RETURNED (1) 3/10CC, 6MM, 31G SYRINGE IN AN OPEN POLY BAG FROM LOT # 0083507. CUSTOMER STATES THAT THERE WAS LIQUID IN THE SYRINGE. THE RETURNED SYRINGE WAS EXAMINED AND NO LIQUID WAS OBSERVED IN THE SYRINGE. THE SAMPLE WAS THEN TESTED AND NO LIQUID CAME OUT OF CANNULA WHEN THE PLUNGER ROD WAS FULLY DEPRESSED. NO DEFECTS WERE OBSERVED ON THE RETURNED SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0189393 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0279520 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0083507 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. ROOT CAUSE: L2L DISPATCH WAS OPENED FOR EXCESSIVE SILICONE BEING PUT INTO THE BARRELS. THE TANK PRESSURE ON SILICONE GUN #1 WAS OUT OF SPECIFICATION. L2L DISPATCH WAS OPENED FOR SILICONE IN THE BARREL ISSUES. SILICONE BUILDUP IN A PROBE/GUN CAN MINIMIZE THE FLOW OF SILICONE IN THAT PROBE THUS FORCING ADDITIONAL SILICONE INTO THE REMAINING GUNS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLES EXPERIENCED FOREIGN MATTER IN FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LIQUID INSIDE OF SYRINGES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0189393, MEDICAL DEVICE EXPIRATION DATE: 2025-07-31, DEVICE MANUFACTURE DATE: 2020-07-07. MEDICAL DEVICE LOT #: 0279520, MEDICAL DEVICE EXPIRATION DATE: 2025-10-31, DEVICE MANUFACTURE DATE: 2020-10-05. MEDICAL DEVICE LOT #: 0083507, MEDICAL DEVICE EXPIRATION DATE: 2025-04-30, DEVICE MANUFACTURE DATE: 2020-03-23. 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 3 BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLES EXPERIENCED FOREIGN MATTER IN FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LIQUID INSIDE OF SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498132 BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324910 SEE H10 00382903249107

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown