BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 15481429 · Received September 24, 2022

    Report

    Report Number
    3003152976-2022-00441
    Event Type
    Malfunction
    Date Received
    September 24, 2022
    Date of Event
    August 15, 2022
    Report Date
    November 10, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903008650
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO PHOTOS OR PHYSICALS SAMPLES THAT DISPLAY THE REPORTED ISSUE WERE PROVIDED FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2203083, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THIS ISSUE WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. LUBRICANT IS EMPLOYED DURING THE SYRINGE ASSEMBLY PROCESS TO LUBRICATE THE CYLINDERS IN THE SILICONE STATION WHICH HELPS FACILITATE EASIER MOVEMENT OF THE PLUNGER. THE SILICONE EMPLOYED IN THIS PRODUCT IS A MEDICAL GRADE SILICONE AUTHORIZED FOR PRODUCT USE. THROUGHOUT THE MANUFACTURING PROCESS, FORCE TESTING AND SILICONE CONTENT TESTS ARE CONDUCTED FOR EACH LOT. TESTING RESULTS WERE REVIEWED FOR LOT 2203083 AND ALL RESULTS WERE FOUND TO BE WITHIN REQUIRED LIMITS. TEN RETAINED SAMPLES OF LOT 2203083 WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGED OR MOLDING DEFECTS WERE OBSERVED AND SILICONE CONTENT AND BREAKOUT FORCE TESTING VERIFIED PRODUCT MET REQUIRED SPECIFICATIONS. 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 THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE#: (B)(6). 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 · 0

    IT WAS REPORTED THAT THE SYRINGE PUMP ALARM WENT OFF FOR OCCLUSION DURING USE OF THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE, AND ONCE REMOVED THE PLUNGER COULD NOT BE MOVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SYRINGE FAILURE DURING CRITICAL INFUSION CHANGE, SYRINGE WAS JAMMED AND NOT WORKING NEAR MISS... THE ISSUE WAS NOT WITH THE PUMP, BUT IT WAS A FAULTY SYRINGE. THE SYRINGE BARREL WAS NOT MOVING, THEREFORE NO DRUG WAS BEING DELIVERED AS THE PUMP ALARMED OCCLUSION. WHEN THE SYRINGE WAS REMOVED STAFF WERE UNABLE TO MOVE THE PLUNGER. THANKFULLY THERE WAS NO LASTING PATIENT HARM DUE TO THE FAULT BEING RECOGNIZED AND A NEW SYRINGE BEING DRAWN UP AND INSERTED INTO THE PUMP. IT WAS AN INOTROPE THAT WAS IN THE SYRINGE AND THE PATIENT DID HAVE A SHORT PERIOD OF HYPOTENSION <2 MINUTES WHILE THE ISSUE WAS BEING DEALT WITH."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE PUMP ALARM WENT OFF FOR OCCLUSION DURING USE OF THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE, AND ONCE REMOVED THE PLUNGER COULD NOT BE MOVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SYRINGE FAILURE DURING CRITICAL INFUSION CHANGE, SYRINGE WAS JAMMED AND NOT WORKING. NEAR MISS... THE ISSUE WAS NOT WITH THE PUMP, BUT IT WAS A FAULTY SYRINGE. THE SYRINGE BARREL WAS NOT MOVING, THEREFORE NO DRUG WAS BEING DELIVERED AS THE PUMP ALARMED OCCLUSION. WHEN THE SYRINGE WAS REMOVED STAFF WERE UNABLE TO MOVE THE PLUNGER. THANKFULLY THERE WAS NO LASTING PATIENT HARM DUE TO THE FAULT BEING RECOGNIZED AND A NEW SYRINGE BEING DRAWN UP AND INSERTED INTO THE PUMP. IT WAS AN INOTROPE THAT WAS IN THE SYRINGE AND THE PATIENT DID HAVE A SHORT PERIOD OF HYPOTENSION <2 MINUTES WHILE THE ISSUE WAS BEING DEALT WITH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2544709 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2203083 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown