BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 14982811 · Received July 11, 2022

    Report

    Report Number
    1213809-2022-00387
    Event Type
    Malfunction
    Date Received
    July 11, 2022
    Date of Event
    June 14, 2022
    Report Date
    July 19, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059165
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1208151. MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2026. DEVICE MANUFACTURE DATE: 27-JUL-2021. MEDICAL DEVICE LOT #: 2024137. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2026. DEVICE MANUFACTURE DATE: 24-JAN-2022. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: SEVENTY-ONE SAMPLES FROM BATCH 1208151 AND TWENTY SAMPLES FROM BATCH 2024137 WERE RECEIVED. NO DEFECTS WERE OBSERVED ON THE SAMPLES FROM BATCH 1208151.ELEVEN OF THE TWENTY SAMPLES FROM BATCH 2024137 WERE FOUND TO BE CLOGGED. THE CLOGGED NEEDLE CONDITION OBSERVED FROM BATCH 2024137 IS NON-CONFORMING PER PRODUCT SPECIFICATION. THE SAMPLES WERE SENT TO THE NEEDLE MANUFACTURING SITE FOR FURTHER EVALUATION AND INVESTIGATION. AT THE NEEDLE MANUFACTURING SITE, ELEVEN SAMPLES WERE RECEIVED. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS THEN CONNECTED TO A SYRINGE WITH SALINE SOLUTION. OF THE ELEVEN SAMPLES FOUR SAMPLES DID NOT EXPEL THE SOLUTION, THESE NEEDLES ARE CLOGGED. IT COULD BE POSSIBLE THAT A PROCESS VARIATION OCCURRED AT THE LUBE STATION INDUCING THE SYMPTOM REPORTED AND NOT DETECTED IN THE NEXT PROCESSES. VERIFICATION OF THE LUBRICATION STATION WAS PERFORMED. THE SETTINGS AND ALIGNMENT OF FIXTURES WAS CORRECT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1208151 AND 2024137. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD SAFETYGLIDE¿ NEEDLE EACH FROM LOTS 1208151 AND 2024137 WERE BLOCKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY THE CUSTOMER THAT WHEN THEY TRY TO PUSH FLUID OR VACCINE THROUGH THE SYRINGE STATES "IT WILL NOT FLOW FREELY THROUGH" AND WHEN THEY PULL BACK ON THE SYRINGE PLUNGER AND SUCKS THE FLUID IN IT LIKE IT'S UNDER PRESSURE.""

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD SAFETYGLIDE¿ NEEDLE EACH FROM LOTS 1208151 AND 2024137 WERE BLOCKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY THE CUSTOMER THAT WHEN THEY TRY TO PUSH FLUID OR VACCINE THROUGH THE THE SYRINGE STATES "IT WILL NOT FLOW FREELY THROUGH" AND WHEN THEY PULL BACK ON THE SYRINGE PLUNGER AND SUCKS THE FLUID IN IT LIKE IT'S UNDER PRESSURE.""

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913501 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 305916 SEE SECTION H10 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown