BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK SYRINGE

    MDR report key: 11143925 · Received January 9, 2021

    Report

    Report Number
    3003152976-2021-00019
    Event Type
    Malfunction
    Date Received
    January 9, 2021
    Date of Event
    December 14, 2020
    Report Date
    March 5, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: 2021-01-15. H6: INVESTIGATION SUMMARY: ONE USED SAMPLE AND ONE EXTENSION LINE WAS RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE TIP OF THE SYRINGE IS OBSERVED TO BE BROKEN AND REMAINED INSIDE THE EXTENSION LINE HUB. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2002202, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PRODUCT UNDERGOES VISUAL AND FUNCTIONAL INSPECTIONS THROUGHOUT MANUFACTURING, INCLUDING TIP AND THREAD VERIFICATIONS. TEN RETAINED SAMPLES OF LOT 2002202 WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS OBSERVED AND ALL PRODUCT WAS VERIFIED TO MEET REQUIRED SPECIFICATIONS. INSPECTION RESULTS WERE REVIEWED LOT 2002202 AND ALL RESULTS WERE FOUND TO BE WITHIN REQUIRED LIMITS. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME. BASED ON THE SAMPLE EVALUATION IT IS POSSIBLE THE TIP BROKE DUE TO EXCESSIVE FORCE WHEN ATTACHING THE DEVICE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD PLASTIPAK¿ LUER-LOK¿ SYRINGES HAD THEIR TIPS SNAP OFF WHEN REMOVING THEM FROM THE SYRINGE DRIVER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THEY HAVE HAD 2 INCIDENTS WITH 2 X 30ML LUER LOK SYRINGES WHEREBY THE TIP HAS SNAPPED FROM THE SYRINGE AS THEY WERE REMOVED FROM THE SYRINGE DRIVER.. THERE WERE NO PATIENT INCIDENTS ON THE BACK OF THIS AND NO INTERVENTIONS."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD PLASTIPAK¿ LUER-LOK¿ SYRINGES HAD THEIR TIPS SNAP OFF WHEN REMOVING THEM FROM THE SYRINGE DRIVER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THEY HAVE HAD 2 INCIDENTS WITH 2 X 30ML LUER LOK SYRINGES WHEREBY THE TIP HAS SNAPPED FROM THE SYRINGE AS THEY WERE REMOVED FROM THE SYRINGE DRIVER. THERE WERE NO PATIENT INCIDENTS ON THE BACK OF THIS AND NO INTERVENTIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40546 BD PLASTIPAK LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2002202

    Patients

    Seq Age Sex Outcome Treatment
    1