BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 13548350 · Received February 17, 2022

    Report

    Report Number
    1911916-2022-00085
    Event Type
    Malfunction
    Date Received
    February 17, 2022
    Date of Event
    February 7, 2022
    Report Date
    June 17, 2024
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051060
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    CORRECTION: ADDITIONAL LOTS WERE PROVIDED BY THE CUSTOMER. THE FOLLOWING FIELDS HAVE BEEN UPDATED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE WAS BLOCKED AND MEDICINE COULDN'T BE PUSHED THROUGH. THIS OCCURRED ONCE EACH IN LOTS 1238429, 9193532, AND 9322397. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 1238429. D.4. MEDICAL DEVICE EXPIRATION DATE: 2026-09-30. H.4. DEVICE MANUFACTURE DATE: 2021-08-26 . D.4. MEDICAL DEVICE LOT #: 9193532. D.4. MEDICAL DEVICE EXPIRATION DATE: 2024-08-31. H.4. DEVICE MANUFACTURE DATE: 2019-07-12 . D.4. MEDICAL DEVICE LOT #: 9322397. D.4. MEDICAL DEVICE EXPIRATION DATE: 2024-12-31. H.4. DEVICE MANUFACTURE DATE: 2019-11-18.

    Additional Manufacturer Narrative · 0

    FOLLOW UP MDR FOR DEVICE EVALUATION. IT WAS REPORTED THE CUSTOMER WAS UNABLE TO PUSH MEDICATION THROUGH THE NEEDLE AS IF IT IS BLOCKED OR DOES NOT HAVE AN OPENING. TO AID IN THE INVESTIGATION, NINETY-FOUR SAMPLES WITH THE PLASTIC SHIELDS, BUT NO PACKAGING BLISTERS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. SIXTY-TWO SAMPLES HAVE NO DEFECTS OR IMPERFECTIONS. THIRTY-TWO SAMPLES HAVE THE NEEDLE BENT AT THE MIDDLE ABOUT THIRTY DEGREES. EACH SAMPLE WAS THEN CONNECTED TO A SYRINGE WITH SALINE SOLUTION. THE SIXTY-TWO SAMPLES EXPELLED THE SOLUTION WITH A NORMAL FLOW. THE THIRTY-TWO SAMPLES WITH THE NEEDLE BENT DID NOT EXPEL THE SOLUTION. THE PROBABLE REASON FOR THE NEEDLE TO NOT EXPEL THE SOLUTION IS THAT THE NEEDLE IS BENT. THIS CONDITION IS NOT HOW THE PRODUCT LEAVES THE MANUFACTURING OPERATION. IT IS UNKNOWN AT WHICH POINT THE NEEDLES WERE BENT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305128, LOT NUMBERS 1238429, 9193532 AND 9322397. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THESE LOTS. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE WAS BLOCKED AND MEDICINE COULDN'T BE PUSHED THROUGH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UNABLE TO PUSH MEDICATION THROUGH THE NEEDLE AS IF IT IS BLOCKED OR DOES NOT HAVE AN OPENING."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE WAS BLOCKED AND MEDICINE COULDN'T BE PUSHED THROUGH. THIS OCCURRED ONCE EACH IN LOTS 1238429, 9193532, AND 9322397. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UNABLE TO PUSH MEDICATION THROUGH THE NEEDLE AS IF IT IS BLOCKED OR DOES NOT HAVE AN OPENING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1862199 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305106 SEE SECTION H10 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown