BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ SP SYRINGE

    MDR report key: 16440518 · Received February 24, 2023

    Report

    Report Number
    3002682307-2023-00032
    Event Type
    Malfunction
    Date Received
    February 24, 2023
    Date of Event
    October 18, 2022
    Report Date
    April 11, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    NGT
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306574 AND LOT NUMBER 2152611. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, FIVE (5) PICTURE SAMPLES WERE PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURE SAMPLES, SEVERAL SHELF CARTONS WERE OBSERVED WITH STAINS AND A SHELF CARTON WAS OBSERVED WITH A HOLE. AS THE SYRINGES WERE NOT PICTURED, WE WERE UNABLE TO CONFIRM IF THE STAINING WAS DUE TO WATER OR INTERNAL SYRINGE LEAKAGE. ACCORDING TO THE CUSTOMER, THE CASE CARTONS WERE IN GOOD CONDITION, SO IT COULD BE THAT THE WATER WAS COMING FROM LEAKAGE OR BREAKAGE OF THE SYRINGES. IF THE PHYSICAL SAMPLES OR ADDITIONAL PICTURES OF THE SYRINGES WERE AVAILABLE, THIS WOULD HELP TO CONFIRM THE CAUSE. HOLES IN SHELF CARTONS MAY RESULT IF THE SECONDARY PACKAGING STATION ARMS ARE NOT WELL ADJUSTED. THE ARMS MAY APPLY TOO MUCH PRESSURE WHEN PLACING THE SYRINGES IN THE SHELF CARTONS, SO THAT THE SYRINGE BREAKS THE CARTON. THIS ISSUE USUALLY AFFECTS THE BOTTOM OF THE SHELF CARTONS. THE MANUFACTURING PLANT HAS LAUNCHED A PROJECT TO CHANGE THE SHELF CARTON MATERIAL FOR ANOTHER MORE ROBUST MATERIAL WITH BETTER CONFORMING PERFORMANCE AT THE PACKAGING STATION, THAT COULD HELP IN PREVENTING SIMILAR DEFECTS FROM OCCURRING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 9 BD POSIFLUSH¿ SP SYRINGES WERE LEAKING IN THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING REDRESSING ACTIVITY FOUND 9 UNITS... WET."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 9 BD POSIFLUSH¿ SP SYRINGES WERE LEAKING IN THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING REDRESSING ACTIVITY FOUND 9 UNITS... WET".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1934806 BD POSIFLUSH¿ SP SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BECTON DICKINSON, S.A. 2152611

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown