BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 10312180 · Received July 23, 2020

    Report

    Report Number
    3003152976-2020-00320
    Event Type
    Malfunction
    Date Received
    July 23, 2020
    Date of Event
    July 3, 2020
    Report Date
    August 14, 2020
    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

    H.6. INVESTIGATION SUMMARY: ONE UNUSED SAMPLE OF LOT 1911213, ONE UNUSED SAMPLE OF LOT 1911298, AND TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION OF THE SAMPLES, THE TIP OF THE SYRINGE IS OBSERVED BROKEN AND THE STOPPER IS NOTED TO BE PARTIALLY DISASSEMBLED FROM THE PLUNGER. THERE WAS NO DAMAGE OR MOLDING DEFECTS IDENTIFIED IN THE PLUNGER ROD THAT COULD HAVE CONTRIBUTED TO THE DETACHED STOPPER. A DEVICE HISTORY REVIEW WAS REPORTED FOR LOTS 1911298 AND 1910213. NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS OF LOT 1911298 THAT COULD HAVE CONTRIBUTED TO THE STOPPER FAILURE. DURING OUR REVIEW OF LOT 1910213, ONE ANNOTATION WAS IDENTIFIED RELATED TO THE BROKEN TIP. DURING THE MOLDING PROCESS OF LOT 1910213, A FAILURE WAS DETECTED IN ONE THE MOLDING CAVITIES WHICH CAUSED THE BARRELS TO BE EXPULSED FROM THE MOLD AND RESULTED IN THE TIP DETACHING. ONCE THE ISSUE WAS DETECTED, THE CAVITY WAS REPAIRED AND DEFECTIVE PRODUCT WAS SCRAPPED. 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. BASED ON OUR INVESTIGATION, THE BROKEN TIP WAS LIKELY OCCURRED AS A RESULT OF BOTH THE MALFUNCTION NOTED DURING MANUFACTURING AND PRODUCT NOT BEING PROPERLY REJECTED. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE IN RELATION TO THE DETACHED STOPPER, IT WAS DETERMINED THIS INCIDENT LIKELY OCCURRED AS A RESULT OF IMPROPER ALIGNMENT OF THE PLUNGER/STOPPER TO THE BARREL DURING ASSEMBLY. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT TO INCREASE AWARENESS OF THIS MATTER. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE IN LOT 1911298 HAD A DEFORMED STOPPER, AND ANOTHER SYRINGE IN LOT 1910213 HAD A MALFORMED LUER TIP. THESE WERE DISCOVERED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE¿VE HAD ONE WITH A DEFORMED BUNG (BN 1911298 EXP 1.10.24 AND OUR REFERENCE (B)(4) AND ONE WITH A MALFORMED NOZZLE AND THREAD."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1911298. MEDICAL DEVICE EXPIRATION DATE: 2024-10-31. DEVICE MANUFACTURE DATE: 2019-11-29. MEDICAL DEVICE LOT #: 1910213. MEDICAL DEVICE EXPIRATION DATE: 2024-09-30. DEVICE MANUFACTURE DATE: 2019-10-07. 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 THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE IN LOT 1911298 HAD A DEFORMED STOPPER, AND ANOTHER SYRINGE IN LOT 1910213 HAD A MALFORMED LUER TIP. THESE WERE DISCOVERED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE¿VE HAD ONE WITH A DEFORMED BUNG (BN 1911298 EXP 1.10.24 AND OUR REFERENCE (B)(4)) AND ONE WITH A MALFORMED NOZZLE AND THREAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782382 BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other