BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE NEEDLE

    MDR report key: 16541769 · Received March 14, 2023

    Report

    Report Number
    1911916-2023-00139
    Event Type
    Malfunction
    Date Received
    March 14, 2023
    Date of Event
    February 6, 2023
    Report Date
    April 4, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051091
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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: 28-MAR-2023 . H6: INVESTIGATION SUMMARY IT WAS REPORTED THERE WAS A HOLE IN THE HUB OF THE NEEDLE. TO AID IN THE INVESTIGATION, ONE SAMPLE WITH NO PACKAGING BLISTER WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED WITH A 10X MAGNIFICATION LENS AND THERE IS A MOLDING SHORT SHOT ABOUT 1/4" FROM THE BOTTOM OF THE NEEDLE HUB. THE SAMPLE WAS THEN CONNECTED TO A SYRINGE WITH SALINE SOLUTION. THERE WAS LEAKAGE OF THE SOLUTION THROUGH THE MOLDING SHORT SHOT. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THERE WAS A PROCESS VARIATION WHILE MOLDING THIS PART. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305109, LOT 2056621. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. THE SAMPLE WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PRECISIONGLIDE NEEDLE EXPERIENCED HOLE IN THE NEEDLE HUB AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE PREPARATION OF AN INJECTION, WE REALIZED THAT THERE WAS A HOLE IN THE HUB OF THE NEEDLE. MAKING SURE THAT THE LIQUID CONTAINED IN THE SYRINGE CAME OUT THROUGH THIS HOLE AS WELL AS THE BEVEL OF THE NEEDLE. THE HOLE IS NOT VISIBLE TO THE EYE. THE NEEDLE WAS PART OF LOT 2053321.ONLY ONE PROBLEMATIC SITUATION HAS BEEN REPORTED SO FAR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PRECISIONGLIDE NEEDLE EXPERIENCED HOLE IN THE NEEDLE HUB AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE PREPARATION OF AN INJECTION, WE REALIZED THAT THERE WAS A HOLE IN THE HUB OF THE NEEDLE. MAKING SURE THAT THE LIQUID CONTAINED IN THE SYRINGE CAME OUT THROUGH THIS HOLE AS WELL AS THE BEVEL OF THE NEEDLE. THE HOLE IS NOT VISIBLE TO THE EYE. THE NEEDLE WAS PART OF LOT 2053321. ONLY ONE PROBLEMATIC SITUATION HAS BEEN REPORTED SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1478824 BD PRECISIONGLIDE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305109 UNKNOWN 30382903051091

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown