BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGES

    MDR report key: 14738824 · Received June 17, 2022

    Report

    Report Number
    3003152976-2022-00275
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    March 30, 2022
    Report Date
    September 28, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2201110, MEDICAL DEVICE EXPIRATION DATE: 31DEC2026, DEVICE MANUFACTURE DATE: 20JAN2022. MEDICAL DEVICE LOT #: 2203035, MEDICAL DEVICE EXPIRATION DATE: 28FEB2027, DEVICE MANUFACTURE DATE: 14FEB2022. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 13JUN2022. ONE USED SAMPLE WAS RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR MOLDING DEFECT WAS OBSERVED THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2201110, 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 2201110 AND ALL RESULTS WERE FOUND TO BE WITHIN REQUIRED LIMITS. TEN RETAINED SAMPLES OF LOT 2201110 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ SYRINGES THE SYRINGE PUMP ALARMS DURING USE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE DPS IS STARTED, THE DEVICE TRIGGERS AN OCCLUSION ALARM. THE CHECKS RELATED TO THIS TYPE OF ALARM ARE CARRIED OUT: VALVE ASSEMBLY, NON-OCCLUSION OF THE CENTRAL LINE. NO ANOMALY WAS FOUND. FINALLY, AFTER SEVERAL ATTEMPTS TO RESTART THE SYSTEM, THE NURSE CHANGES THE SYRINGE PUMP AND PREPARES A NEW SYRINGE, BUT THE SYSTEM IS NOT READY FOR USE. AND PREPARED A NEW SYRINGE, BUT THIS TIME IN A 50 ML BD PLASTIPAK SYRINGE SO THAT THE DEVICE DOES NOT ALARM WHILE MAINTAINING THE PRESSURE LIMITS (SET BY DEFAULT AT P=300 MMHG AND NOT CHANGEABLE BY USERS).

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ SYRINGES THE SYRINGE PUMP ALARMS DURING USE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE DPS IS STARTED, THE DEVICE TRIGGERS AN OCCLUSION ALARM. THE CHECKS RELATED TO THIS TYPE OF ALARM ARE CARRIED OUT: VALVE ASSEMBLY, NON-OCCLUSION OF THE CENTRAL LINE. NO ANOMALY WAS FOUND. FINALLY, AFTER SEVERAL ATTEMPTS TO RESTART THE SYSTEM, THE NURSE CHANGES THE SYRINGE PUMP AND PREPARES A NEW SYRINGE, BUT THE SYSTEM IS NOT READY FOR USE. AND PREPARED A NEW SYRINGE, BUT THIS TIME IN A 50 ML BD PLASTIPAK SYRINGE SO THAT THE DEVICE DOES NOT ALARM WHILE MAINTAINING THE PRESSURE LIMITS (SET BY DEFAULT AT P=300 MMHG AND NOT CHANGEABLE BY USERS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1311394 BD PLASTIPAK¿ SYRINGES PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2202066

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown