BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 17808041 · Received September 25, 2023

    Report

    Report Number
    1213809-2023-01062
    Event Type
    Malfunction
    Date Received
    September 25, 2023
    Date of Event
    August 8, 2023
    Report Date
    January 23, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059165
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ NEEDLE WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THREE (3) LPNS(LICENSED PRACTICAL NURSES) BROUGHT SAFETY GLIDE NEEDLES THAT MALFUNCTION - TOTAL OF 7 NEEDLES. THEY STATED THAT THEY THEN TRIED ANOTHER NEEDLE (SAME LOT) AND THEY WORKED. THIS WAS THE 25G X 1 INCH SAFETYGLIDE NEEDLE."

    Additional Manufacturer Narrative · 0

    PR 8840136 FOLLOW UP. IT WAS REPORTED THE NEEDLES MALFUNCTIONED. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE COMPLETED. A DEVICE HISTORY RECORD WAS REVIEWED FOR PROVIDED MATERIAL NUMBER 305916, LOT 2024138. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 2024138 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. ADDITIONAL DEVICE HISTORIES WERE REVIEWED FOR EACH BATCH OF NEEDLES USED IN THE MANUFACTURING OF THIS BATCH. THERE WAS NO DOCUMENTATION OF THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THESE BATCH NUMBERS. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT PROCESS VARIATIONS DURING THE NEEDLE LUBRICANT APPLICATION CAN INDUCE CLOGGED NEEDLES. SEVERAL QUALITY INITIATIVES HAVE BEEN IMPLEMENTED IN THE MANUFACTURING PROCESS TO ENSURE THE NEEDLE LUBRICATION IS APPLIED APPROPRIATELY. ADDITIONALLY, A MONITORING PROGRAM IS ALSO IN PLACE TO VERIFY THE NEEDLE LUBRICANT IS APPLIED UNIFORMLY TO THE NEEDLE. BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    E.4. FDA NOTIFIED?: THE INITIAL REPORTER ALSO NOTIFIED THE FDA VIA MEDWATCH # MW5144841. H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ NEEDLE WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THREE (3) LPNS(LICENSED PRACTICAL NURSES) BROUGHT SAFETY GLIDE NEEDLES THAT MALFUNCTION - TOTAL OF 7 NEEDLES. THEY STATED THAT THEY THEN TRIED ANOTHER NEEDLE (SAME LOT) AND THEY WORKED. THIS WAS THE 25G X 1 INCH SAFETYGLIDE NEEDLE."

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED. MAT#: 305916, BATCH#: 2024138. IT WAS REPORTED BY CUSTOMER THAT THREE (3) LPNS (LICENSED PRACTICAL NURSES) BROUGHT SAFETY GLIDE NEEDLES THAT MALFUNCTION - TOTAL OF 7 NEEDLES. THEY STATED THAT THEY THEN TRIED ANOTHER NEEDLE (SAME LOT) AND THEY WORKED. THIS WAS THE 25G X 1-INCH SAFETYGLIDE NEEDLE. VERBATIM: RCC RECEIVED COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THREE (3) LPNS(LICENSED PRACTICAL NURSES) BROUGHT SAFETY GLIDE NEEDLES THAT MALFUNCTION - TOTAL OF 7 NEEDLES. THEY STATED THAT THEY THEN TRIED ANOTHER NEEDLE (SAME LOT) AND THEY WORKED. THIS WAS THE 25G X 1 INCH SAFETYGLIDE NEEDLE. REFERENCE REPORTS: MW5144840, MW5144842, MW5144843, MW5144844, MW5144845, MW5144846. 20SEP2023 ADDITIONAL INFORMATION RECEIVED FOR PR 8860893 STATES, ¿WHEN MEDICINE WAS DRAWN UP IN THE SYRINGE & NURSE WENT TO ADVANCE THE PLUNGER IT WOULD NOT ADVANCE.¿

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ NEEDLE MALFUNCTIONED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THREE (3) LPNS(LICENSED PRACTICAL NURSES) BROUGHT SAFETY GLIDE NEEDLES THAT MALFUNCTION - TOTAL OF 7 NEEDLES. THEY STATED THAT THEY THEN TRIED ANOTHER NEEDLE (SAME LOT) AND THEY WORKED. THIS WAS THE 25G X 1 INCH SAFETYGLIDE NEEDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1515217 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 2024138 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown