BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PERFUSION¿ SYRINGE W/NEEDLE

    MDR report key: 7666447 · Received July 6, 2018

    Report

    Report Number
    3003152976-2018-00273
    Event Type
    Malfunction
    Date Received
    July 6, 2018
    Date of Event
    June 13, 2018
    Report Date
    August 16, 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: TWO USED SAMPLES FROM LOT NUMBER 1803210 AND ONE UNUSED SAMPLE FROM LOT NUMBER 1803211 WERE RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER. UPON VISUAL INSPECTION OF THE TWO USED SAMPLES, LEAKAGE CAN BE OBSERVED BETWEEN THE STOPPER RIBS. THE SAMPLES WERE DISASSEMBLED AND THE STOPPER WAS OBSERVED CORRECTLY ASSEMBLED TO THE PLUNGER WITH NO DAMAGES OR DEFECTS OBSERVED. VISUAL INSPECTION OF THE UNUSED SAMPLE DID NOT REVEAL ANY DAMAGES OR DEFECTS. TEN RETAINED SAMPLES OF EACH LOT NUMBER WERE OBTAINED FOR FURTHER INVESTIGATION. UPON VISUAL INSPECTION OF THESE TWENTY RETAINED SAMPLES, NO DAMAGES WERE OBSERVED. LEAKAGE TESTING WAS PERFORMED ON THE TWENTY RETAINED SAMPLES AND LEAKAGE DID NOT OCCUR. A DEVICE HISTORY RECORD REVIEW OF LOTS 1803210 AND 1803211 DID NOT REVEAL ANY DEVIATIONS OR NON-CONFORMANCES DURING THE PRODUCTION OF LOTS 1803210 AND 1803211 THAT COULD HAVE CONTRIBUTED TO THE DEFECT OF LEAKAGE. BASED ON THE INVESTIGATION, A CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. THIS ISSUE IS NOT RELATED TO A MANUFACTURING DEFECT. SINCE NO INCIDENCE HAS BEEN FOUND IN DHR REVIEW, RETAINED SAMPLES AND UNUSED SAMPLE RECEIVED EVALUATED MEET ISO7886 ANNEX D, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED FOR LEAKAGE IN THIS LOT. NO FORMAL CAPA IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURER: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING A BD PERFUSION¿ SYRINGE W/NEEDLE, THE CUSTOMER EXPERIENCED LEAKAGE WITH THE DEVICE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING A BD PERFUSION¿ SYRINGE W/NEEDLE, THE CUSTOMER EXPERIENCED LEAKAGE WITH THE DEVICE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN USING A BD PERFUSION¿ SYRINGE W/NEEDLE, THE CUSTOMER EXPERIENCED LEAKAGE WITH THE DEVICE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507878 BD PERFUSION¿ SYRINGE W/NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON, S.A. 1803210

    Patients

    Seq Age Sex Outcome Treatment
    1 Other