BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 12047041 · Received June 22, 2021

    Report

    Report Number
    3003152976-2021-00337
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    April 27, 2021
    Report Date
    July 27, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVALUATION?: YES. D.10. RETURNED TO MANUFACTURER ON: 6/22/2021. H.6. INVESTIGATION: FOUR UNUSED SYRINGES AND ONE PHOTO OF THE IMPACTED PRODUCT WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION OF THE PHOTO, THE TIP IS OBSERVED TO BE COMPLETELY DETACHED FROM THE SYRINGE, NO OTHER VISIBLE DEFECTS CAN BE OBSERVED. UPON EVALUATION OF THE UNUSED DEVICES THAT WERE RETURNED, NO DAMAGE OR MOLDING DEFECTS WERE OBSERVED IN THE TIPS AND ALL TIPS ARE FIRMLY ATTACHED TO THE SYRINGE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2010110, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THERE HAVE BEEN NO CHANGES IN THE MATERIALS OR PROCESS USED TO MANUFACTURE THIS PRODUCT THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES, INCLUDING TIP AND THREAD VERIFICATION TESTING. ALL RESULTS WERE REVIEWED FOR LOT 2010110 AND FOUND TO BE WITHIN SPECIFICATION. BASED ON OUR INVESTIGATION AND GIVEN THE DEVICE RECORDS DID NOT IDENTIFY ANY FAILURES RELATED TO THIS INCIDENT, WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP OF THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE BROKE OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TIP OF 50ML BD PLASTIPAK SYRINGE HAS SNAPPED OFF/SHATTERED AND BECAME LODGED IN REVERSE LUER-LOK OF ROPIVACAINE SINGLE-INFUSER BALL THIS PM WHEN NS WERE FILLING.".

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE BROKE OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TIP OF 50ML BD PLASTIPAK SYRINGE HAS SNAPPED OFF/SHATTERED AND BECAME LODGED IN REVERSE LUER-LOK OF ROPIVACAINE SINGLE-INFUSER BALL THIS PM WHEN NS WERE FILLING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942447 BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2010110

    Patients

    Seq Age Sex Outcome Treatment
    1