BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 16968422 · Received May 19, 2023

    Report

    Report Number
    1213809-2023-00539
    Event Type
    Malfunction
    Date Received
    May 19, 2023
    Date of Event
    April 27, 2023
    Report Date
    June 8, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    10612479248578
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED BATCH NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 2172849. D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2027. H4. DEVICE MANUFACTURE DATE: 21-JUN-2022. D4. MEDICAL DEVICE LOT #: 2202914. D4. MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2027. H4. DEVICE MANUFACTURE DATE: 21-JUL-2022. D4. MEDICAL DEVICE LOT #: 2188472. D4. MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2027. H4. DEVICE MANUFACTURE DATE: 07-JUL-2022.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNSPECIFIED NUMBER OF BD SAFETYGLIDE¿ NEEDLE EXPERIENCED OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLES ARE DIFFICULT TO DRAW UP MEDS WITH, LIKE THERE IS NO NEGATIVE PRESSURE TO HELP FILL THE SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNSPECIFICED NUMBER OF BD SAFETYGLIDE¿ NEEDLE EXPERIENCED OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLES ARE DIFFICULT TO DRAW UP MEDS WITH, LIKE THERE IS NO NEGATIVE PRESSURE TO HELP FILL THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1076003 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 192-N251S SEE H10 10612479248578

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown