BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 11670769 · Received April 15, 2021

    Report

    Report Number
    3003152976-2021-00200
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    March 16, 2021
    Report Date
    May 6, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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: 2021-03-29 . H6: INVESTIGATION SUMMARY ONE USED SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, AIR BUBBLES WITHIN THE WATER CONTAINED IN THE SYRINGE AND A LEAKAGE PAST THE STOPPER WERE OBSERVED. THE SYRINGES WERE EMPTIED, CLEANED, AND FILLED WITH WATER, NO AIR BUBBLES WERE OR OTHER ABNORMALITIES WERE SEEN WITHIN THE SYRINGE. THE PRODUCT WAS DISASSEMBLED FOR FURTHER EVALUATION, THERE WAS NO DAMAGE OR MOLDING DEFECTS IDENTIFIED IN THE PLUNGER ROD OR OTHER COMPONENTS AND THE STOPPERS WERE VERIFIED TO BE PROPERLY ASSEMBLED ONTO THE PLUNGER. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2010100, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. 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 TIGHTNESS TESTS TO VERIFY THE SEAL OF THE STOPPER. RESULTS WERE REVIEWED FOR THE REPORTED LOT AND NO ISSUES WERE IDENTIFIED DURING MANUFACTURING. THE SAMPLE UNDERWENT THESE TESTS AND FOUND IN ALL CASES THE PRODUCT MET REQUIRED SPECIFICATION. NO CHANGES HAVE BEEN MADE IN THE MATERIAL OR MANUFACTURING PROCESS FOR THIS PRODUCT. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VARIOUS FACTS WERE NOTED WITH THIS BATCH SUCH AS LARGE AIR BUBBLES AND LEAKS AT THE LEVEL OF THE PISTON. FOR THE MOMENT, THERE ARE NO CLINICAL CONSEQUENCES OBSERVED, BUT THIS CAN GENERATE A RISK. AN OPEN SYRINGE OF THIS BATCH WITH WATER HAS BEEN RETURNED TO ME BY THE DEPARTMENT AND I HAVE ASKED ALL THE DEPARTMENTS HAVING THIS BATCH TO BRING IT BACK TO THE PHARMACY FOR QUARANTINE WHILE YOUR EXPERTISE IS CARRIED OUT. DATE OF OCCURRENCE: (B)(6) 2021 1/THIS MORNING, A HEALTHCARE WORKER NOTICED THAT A SYRINGE CONNECTED TO A PSE (ELECTRIC SYRINGE PUMP) HAD A VERY LARGE AIR BUBBLE INSIDE. 2/ WHILE TRYING TO RE-DO A SYRINGE, ANOTHER SYRINGE STARTED TO LEAK THROUGH THE PLUNGER. 3/ ANOTHER NURSE NOTICED AIR IN A PREPARED BUT UNCONNECTED SYRINGE ALTHOUGH IT HAD BEEN HAD BEEN PURGED. CLINICAL CONSEQUENCES OBSERVED: FOR THE MOMENT NONE. PROTECTIVE MEASURES AND ACTIONS TAKEN: CALL TO THE CLINICIAN WITHDRAWAL OF THE BATCHES CONCERNED

    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 BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VARIOUS FACTS WERE NOTED WITH THIS BATCH SUCH AS LARGE AIR BUBBLES AND LEAKS AT THE LEVEL OF THE PISTON. FOR THE MOMENT, THERE ARE NO CLINICAL CONSEQUENCES OBSERVED, BUT THIS CAN GENERATE A RISK. AN OPEN SYRINGE OF THIS BATCH WITH WATER HAS BEEN RETURNED TO ME BY THE DEPARTMENT AND I HAVE ASKED ALL THE DEPARTMENTS HAVING THIS BATCH TO BRING IT BACK TO THE PHARMACY FOR QUARANTINE WHILE YOUR EXPERTISE IS CARRIED OUT. DATE OF OCCURRENCE: (B)(6) 2021 1/THIS MORNING, A HEALTHCARE WORKER NOTICED THAT A SYRINGE CONNECTED TO A PSE (ELECTRIC SYRINGE PUMP) HAD A VERY LARGE AIR BUBBLE INSIDE. 2/ WHILE TRYING TO RE-DO A SYRINGE, ANOTHER SYRINGE STARTED TO LEAK THROUGH THE PLUNGER. 3/ ANOTHER NURSE NOTICED AIR IN A PREPARED BUT UNCONNECTED SYRINGE ALTHOUGH IT HAD BEEN HAD BEEN PURGED. CLINICAL CONSEQUENCES OBSERVED: FOR THE MOMENT NONE. PROTECTIVE MEASURES AND ACTIONS TAKEN: CALL TO THE CLINICIAN WITHDRAWAL OF THE BATCHES CONCERNED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568380 BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 2010100

    Patients

    Seq Age Sex Outcome Treatment
    1