BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 ML BD POSIFLUSH NORMAL SALINE SYRINGE

    MDR report key: 11916401 · Received June 1, 2021

    Report

    Report Number
    1911916-2021-00499
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    April 29, 2021
    Report Date
    June 4, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-06-03. H6: INVESTIGATION SUMMARY: IT WAS REPORTED IT WAS HARD TO PUSH THE PLUNGER OF THE SYRINGE AND RESISTANCE FORCE OCCURRED AT 5ML. TO AID IN THE INVESTIGATION, ONE SAMPLE WITH NO PACKAGING FLOW WRAP AND ONE PHOTO WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. THE RUBBER STOPPER IS AT 5ML OF THE SCALE AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE SAMPLE WAS THEN TESTED FOR SUSTAINING FORCE, WHICH IS THE FORCE APPLIED TO THE PLUNGER ROD WHILE MOVING DOWNWARDS WHEN EXPELLING THE SALINE SOLUTION, AND THE RESULT WAS WITHIN SPECIFICATION. THE PHOTO PROVIDED SHOWS THE SAMPLE RECEIVED. IT COULD BE POSSIBLE THE CUSTOMER HAD PRODUCT ON THE HIGHER END OF SPECIFICATION INDUCING MORE FORCE THAN NORMAL REQUIRED TO EXPEL THE SOLUTION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306546, LOT NUMBER 0223825. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER OF PLUNGER MOVEMENT DIFFICULT WAS NOT CONFIRMED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE EXPERIENCED DIFFICULT PLUNGER MOVEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER COMPLAINED THAT IT WAS HARD TO PUSH THE PLUNGER OF THE SYRINGE AND RESISTANCE FORCE OCCURRED AT 5ML. THE USER DISCONNECTED THE SYRINGE AND TRIED TO USE ANOTHER POSIFLUSH, THE PATHWAY WAS UNBLOCKED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER ADDR 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 THAT THE 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE EXPERIENCED DIFFICULT PLUNGER MOVEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER COMPLAINED THAT IT WAS HARD TO PUSH THE PLUNGER OF THE SYRINGE AND RESISTANCE FORCE OCCURRED AT 5ML. THE USER DISCONNECTED THE SYRINGE AND TRIED TO USE ANOTHER POSIFLUSH, THE PATHWAY WAS UNBLOCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809863 10 ML BD POSIFLUSH NORMAL SALINE SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 0223825

    Patients

    Seq Age Sex Outcome Treatment
    1