BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PERFUSION¿ SYRINGE W/NEEDLE

    MDR report key: 7768718 · Received August 9, 2018

    Report

    Report Number
    3003152976-2018-00347
    Event Type
    Malfunction
    Date Received
    August 9, 2018
    Date of Event
    July 20, 2018
    Report Date
    September 13, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE USED SAMPLE UNIT AND ONE PICTURE SAMPLE WERE RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER. UPON VISUAL INSPECTION OF THE SAMPLES, LEAKAGE WAS OBSERVED PAST THE STOPPER RIBS. NO DAMAGES OR MOLDING DEFECTS COULD BE FOUND AND THE STOPPER WAS CORRECTLY ASSEMBLED TO THE PLUNGER. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY DOCUMENTED ISSUES DURING THE PRODUCTION OF THE POTENTIAL LOT NUMBERS PROVIDED (1801221, 1801217, AND 1803209) THAT COULD HAVE CONTRIBUTED TO THE LEAKAGE. SILICONE CONTENT TESTS AND BREAK-OUT SUSTAINING FORCE TESTS ARE PERFORMED DURING THE MANUFACTURING PROCESS. AS THE SYRINGES ARE INTENDED FOR SINGLE USE, FUNCTIONALITY TESTING ON THE PROVIDED SAMPLE WOULD NOT BE RELIABLE, THEREFORE, TEN ADDITIONAL RETAINED SAMPLES OF EACH LOT NUMBER WERE EVALUATED. LEAKAGE TESTING WAS PERFORMED ON ALL THIRTY RETAINED SAMPLES AND ALL SAMPLES PERFORMED ACCORDING TO PROCEDURE. THE SAMPLES WERE DISASSEMBLED AND NO DAMAGES COULD BE OBSERVED TO ANY COMPONENTS. BASED ON THE INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. SINCE NO MANUFACTURING DEFECT HAS BEEN FOUND, CORRECTIVE ACTION IS NOT TAKEN.

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURER: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD PERFUSION¿ SYRINGE W/NEEDLE LEAKED WHEN THE NURSE FOUND THAT DURING AN ANTIBIOTIC INFUSION, THE BLOOD FROM THE PATIENT HAD LEAKED INTO THE LINE AND PAST THE PISTON. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD PERFUSION¿ SYRINGE W/NEEDLE LEAKED WHEN THE NURSE FOUND THAT DURING AN ANTIBIOTIC INFUSION, THE BLOOD FROM THE PATIENT HAD LEAKED INTO THE LINE AND PAST THE PISTON. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 A BD PERFUSION¿ SYRINGE W/NEEDLE LEAKED WHEN THE NURSE FOUND THAT DURING AN ANTIBIOTIC INFUSION, THE BLOOD FROM THE PATIENT HAD LEAKED INTO THE LINE AND PAST THE PISTON. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607349 BD PERFUSION¿ SYRINGE W/NEEDLE SYRINGE FMF BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other