BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE

    MDR report key: 8908171 · Received August 19, 2019

    Report

    Report Number
    1911916-2019-00838
    Event Type
    Malfunction
    Date Received
    August 19, 2019
    Date of Event
    July 22, 2019
    Report Date
    September 10, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051060
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: FORTY-SIX (46) SAMPLES WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION IN UNOPENED BLISTER PACKS. ALL FORTY-SIX (46) SAMPLES WERE VISUALLY EXAMINED AND ONE (1) WAS FOUND TO BE CLOGGED AS LIGHT WAS NOT ABLE TO PASS THROUGH THE NEEDLE. THE OTHER FORTY-FIVE (45) SAMPLES WERE FOUND NOT TO BE CLOGGED AS LIGHT WAS ABLE TO PASS THROUGH THE NEEDLE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCH ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEWS DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. FOREIGN MATERIAL (FM) CAN BE INTRODUCED TO THE FLUID PATH DURING THE MANUFACTURING PROCESS WHICH COULD CAUSE THE NEEDLE TO BECOME CLOGGED. ALL PRODUCT IS AUTOMATICALLY CHECKED FOR CLOGGED NEEDLES DURING THE PRODUCTION PROCESS.

    Description of Event or Problem · 0

    MATERIAL NO. 305106. BATCH NO. 8324761. IT WAS REPORTED THAT DURING USE OF THE BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE THE PLUNGER MOVEMENT WAS DIFFICULT. THE PLUNGER WOULD NOT ADVANCE. THIS OCCURRED ON 2 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPON ATTEMPTING TO PRESS THE MEDICATION FOR PURGING PURPOSES, IT WAS NOTED THAT THE PLUNGER ON THE SYRINGE WOULD NOT ADVANCE NO MATTER HOW MUCH PRESSURE WAS PLACED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO. 305106, BATCH NO. 8324761. IT WAS REPORTED THAT DURING USE OF THE BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE THE PLUNGER MOVEMENT WAS DIFFICULT. THE PLUNGER WOULD NOT ADVANCE. THIS OCCURRED ON 2 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPON ATTEMPTING TO PRESS THE MEDICATION FOR PURGING PURPOSES, IT WAS NOTED THAT THE PLUNGER ON THE SYRINGE WOULD NOT ADVANCE NO MATTER HOW MUCH PRESSURE WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698776 BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 8324761 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other