BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G

    MDR report key: 15397764 · Received September 10, 2022

    Report

    Report Number
    1213809-2022-00555
    Event Type
    Malfunction
    Date Received
    September 10, 2022
    Date of Event
    August 5, 2022
    Report Date
    September 14, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    00382903059164
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 06-SEP-2022. H6: INVESTIGATION SUMMARY. THIRTY-EIGHT SAMPLES FROM BATCH 2007149 WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. TWENTY SAMPLES WERE RANDOMLY SELECTED FOR EVALUATION. UPON VISUAL INSPECTION, NO DEFECTS OR ISSUES WERE OBSERVED. FUNCTIONAL TESTING WAS PERFORMED, EACH SAMPLE WAS CONNECTED TO A SYRINGE WITH SALINE SOLUTION. ALL THE SAMPLES EXPELLED THE SOLUTION WITH NORMAL FLOW. NO SAMPLES WERE RECEIVED FROM BATCH 2003405. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBERS 2007149 AND 2003405. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2007149, MEDICAL DEVICE EXPIRATION DATE: 31DEC2026, DEVICE MANUFACTURE DATE: 07JAN2022. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G THE NEEDLE WAS CLOGGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: IT WAS REPORTED BY THE CUSTOMER THAT THE SAFETYGLIDE NEEDLE WAS OCCLUDED AND UNABLE TO DRAW UP SOLUTION. DATE OF INCIDENT (B)(6) 2022. MPN 305916. LOT #S 2007149 & 2003405.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G THE NEEDLE WAS CLOGGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE SAFETYGLIDE NEEDLE WAS OCCLUDED AND UNABLE TO DRAW UP SOLUTION. DATE OF INCIDENT: ON (B)(6) 2022. MPN 305916, LOT#S: 2007149 & 2003405.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360294 BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 2003405 00382903059164

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown