BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1ML LS 25GA 5/8IN

    MDR report key: 9161768 · Received October 7, 2019

    Report

    Report Number
    8041187-2019-00791
    Event Type
    Malfunction
    Date Received
    October 7, 2019
    Date of Event
    September 20, 2019
    Report Date
    October 30, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD RECEIVED 33 1ML 25 GAUGE SYRINGES FROM LOT 8110427 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNITS AND OBSERVED NO PHYSICAL/MECHANICAL DEFECTS. A PLUNGER BREAKOUT AND SUSTAINING FORCE TEST WAS PERFORMED ON THE UNITS AND EACH UNIT PASSED AND WAS FOUND TO BE WITHIN PRODUCT SPECIFICATIONS. BASED OFF THE VISUAL INSPECTION AND TESTING THE ENGINEER WAS UNABLE TO VERIFY THE REPORTED DEFECT. SINCE NO DEFECTS WERE OBSERVED DURING INSPECTION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. BASED ON THE PLUNGER BREAKOUT AND SUSTAINING FORCE TEST RESULT OF SAMPLES RETURNED, THE PLUNGER BREAKOUT FORCE TEST WAS PERFORMED AND DETERMINED TO BE MAX 2.466LBF WHICH HAD PASSED THE PRODUCT SPECIFICATION OF 2.5LBF (MAX). THE PLUNGER SUSTAINING FORCE TEST WAS PERFORMED AND DETERMINED TO BE MAX 1.047LBF WHICH HAD PASSED THE PRODUCT SPECIFICATION OF 1.0LBF (MAX). THE ACTUAL SAMPLES PASSED THE PLUNGER BREAKOUT AND SUSTAINING FORCE TEST SPECIFICATION. HENCE ROOT CAUSE COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE IT WAS DISCOVERED THAT THE PLUNGER DIFFICULT TO USE WITH A BD SYRINGE 1ML LS 25GA 5/8IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THIS BATCH OF 1 ML SYRINGES IS GENERALLY LESS PROBLEMATIC WITH LUBRICANTS. WHEN THE NURSES PUMPED THE DRUGS, THEY FOUND IT VERY DIFFICULT AND REQUIRED LABORIOUS OPERATION, WHICH CAUSED GREAT INCONVENIENCE TO THE CLINICAL WORK.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: 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 PRIOR TO USE IT WAS DISCOVERED THAT THE PLUNGER DIFFICULT TO USE WITH A BD SYRINGE 1ML LS 25GA 5/8IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THIS BATCH OF 1 ML SYRINGES IS GENERALLY LESS PROBLEMATIC WITH LUBRICANTS. WHEN THE NURSES PUMPED THE DRUGS, THEY FOUND IT VERY DIFFICULT AND REQUIRED LABORIOUS OPERATION, WHICH CAUSED GREAT INCONVENIENCE TO THE CLINICAL WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958755 BD SYRINGE 1ML LS 25GA 5/8IN SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 8110427

    Patients

    Seq Age Sex Outcome Treatment
    1 Other