BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 7620665 · Received June 20, 2018

    Report

    Report Number
    3003152976-2018-00255
    Event Type
    Malfunction
    Date Received
    June 20, 2018
    Date of Event
    May 25, 2018
    Report Date
    July 18, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: LOT NUMBER 1801264 FOR PRODUCT 300865 WAS RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER. AS SAMPLES WERE NOT PROVIDED FOR INVESTIGATION, TEN RETAINED SAMPLES OF THE REPORTED LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY. NO DAMAGES WERE OBSERVED TO THE TIPS OF THE RETAINED SAMPLES, ALL WERE WITHIN SPECIFICATIONS. NO DAMAGES OR MOLDING DEFECTS WERE OBSERVED TO ANY OF THE RETAINED SAMPLES THAT MAY HAVE CAUSED LEAKAGE, THE STOPPERS WERE CORRECTLY ASSEMBLED TO THE PLUNGERS WITHIN EACH SAMPLE. LEAKAGE TESTING WAS PERFORMED ON THE RETAINED SAMPLES AND LEAKAGE WAS NOT OBSERVED. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY DEVIATIONS OR NON-CONFORMANCES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECTS. THIS IS THE FIRST COMPLAINT OF LEAKAGE PAST STOPPER AND TIP BENT FOR PRODUCT CODE 300865 AND LOT NUMBER 1801264. BASED ON THE DEVICE HISTORY RECORD REVIEW AND THE RETAINED SAMPLE INVESTIGATION, A DEFINITE CAUSE FOR THE REPORTED INCIDENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE THERE WAS AN ISSUE WITH LEAKAGE. IT WAS STATED ¿THE 50ML LUER LOCK SYRINGE HAD A BENT TIP AND WOULD NOT LOCK INTO THE GIVING SET FOR DELIVERING SYRINGE DRIVER SEDATION. I HAD A GIVING SET WITH A HOLE SPLASHING PROPOFOL EVERYWHERE AND ANOTHER SYRINGE WHERE THE PROPOFOL LEAKS BEHIND THE RUBBER STOPPER AT THE END OF THE SYRINGE WHICH RISKS AWARENESS UNDER ANESTHETIC IF THE ADEQUATE AMOUNT OF THE DRUG IS NOT DELIVERED.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    (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 · 1

    IT WAS REPORTED WITH THE USE OF THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE THERE WAS AN ISSUE WITH LEAKAGE. IT WAS STATED ¿THE 50ML LUER LOCK SYRINGE HAD A BENT TIP AND WOULD NOT LOCK INTO THE GIVING SET FOR DELIVERING SYRINGE DRIVER SEDATION. I HAD A GIVING SET WITH A HOLE SPLASHING PROPOFOL EVERYWHERE AND ANOTHER SYRINGE WHERE THE PROPOFOL LEAKS BEHIND THE RUBBER STOPPER AT THE END OF THE SYRINGE WHICH RISKS AWARENESS UNDER ANESTHETIC IF THE ADEQUATE AMOUNT OF THE DRUG IS NOT DELIVERED.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464642 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1801264

    Patients

    Seq Age Sex Outcome Treatment
    1 Other