BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 17927412 · Received October 12, 2023

    Report

    Report Number
    1213809-2023-01133
    Event Type
    Malfunction
    Date Received
    October 12, 2023
    Date of Event
    June 27, 2023
    Report Date
    January 24, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    10612479248578
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2188472. D.4. MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2027. H.4. DEVICE MANUFACTURE DATE: 07-JUL-2022. D.4. MEDICAL DEVICE LOT #: 2202913. D.4. MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2027. H.4. DEVICE MANUFACTURE DATE: 21-JUL-2022. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4) ¿ FOLLOW UP MDR FOR DEVICE EVALUATION IT WAS REPORTED THE NEEDLES SEEMED TO BE BLOCKED. TO AID IN THE INVESTIGATION, THREE HUNDRED FORTY-NINE SAMPLES IN SEALED PACKAGING BLISTERS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. TWO HUNDRED NINETY-NINE SAMPLES WERE FROM LOT 2188472 AND FORTY SAMPLES WERE FROM LOT 2202913. FIFTY SAMPLES WERE RANDOMLY SELECTED FROM LOT 2188472 AND TWENTY SAMPLES WERE RANDOMLY SELECTED FROM LOT 2202913. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS THEN CONNECTED TO A SYRINGE WITH SALINE SOLUTION. FROM LOT 2188472, THREE SAMPLES DID NOT EXPEL THE SOLUTION. ALL THE REMAINING SELECTED SAMPLES FROM BOTH LOT EXPELLED THE SOLUTION WITH A NORMAL FLOW. PREVIOUS INVESTIGATIONS HAVE REVEALED THAT PROCESS VARIATIONS DURING THE NEEDLE LUBRICANT APPLICATION CAN CREATE CLOGGED NEEDLES. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER (B)(4), LOTS 2188472 AND 2202913. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. LOTS 2188472 AND 2202913 WERE 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. DURING THE HISTORY REVIEW, THERE WERE LOTS IDENTIFIED AS HAVING SUFFERED FROM CLOGGED NEEDLES DUE TO SILICONE. IT COULD BE POSSIBLE SOME SAMPLES ARE ESCAPES FROM THE INCIDENT THAT OCCURRED DURING PRODUCTION. 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 THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER BE CONFIRMED. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ NEEDLE WAS BLOCKED. LOT#: 2188472 AND 2202913. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLES SEEM TO BE BLOCKED AS IT DOES NOT ALLOW TO PUSH OUT THE LIQUID FOR THE INJECTION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1969184 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS SEE H.10 10612479248578

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown