BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ SF SALINE SYRINGE

    MDR report key: 15825360 · Received November 18, 2022

    Report

    Report Number
    9616657-2022-00039
    Event Type
    Malfunction
    Date Received
    November 18, 2022
    Date of Event
    October 26, 2022
    Report Date
    December 28, 2022
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    00382903065530
    PMA / PMN Number
    K153481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306553 AND LOT NUMBER 2110682. THE REVIEW DID NOT REVEAL ANY NON-CONFORMANCES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) PHYSICAL SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. FOURIER-TRANSFORM INFRARED (FTIR) SPECTROSCOPY WAS PERFORMED ON THE FOREIGN MATERIAL. BASED ON THE FTIR RESULTS AND AN INSPECTION OF THE FOREIGN MATERIAL, IT WAS DETERMINED THAT THE MATERIAL WAS MOST LIKELY A PIECE OF A SUCTION CUP OR BRAKE HOSE IN THE MULTIVAC MACHINE. IN ORDER TO CONFIRM THIS DETERMINATION, THE PIECE OF FOREIGN MATERIAL ALONG WITH SAMPLES OF A SUCTION CUP AND BRAKE HOSE WERE SENT FOR COMPARISON TESTING. THE COMPARISON TEST RESULTS CONFIRMED THAT THE FOREIGN MATERIAL WAS MOST LIKELY A PIECE OF THE BRAKE HOSE FROM THE MULTIVAC. THE MOST PROBABLE CAUSE FOR THIS INCIDENT IS RELATED TO THE WEARING OF THE HYDRAULIC TUBING WITHIN THE BRAKE HOUSING OF THE MULTIVAC. IN ORDER TO PREVENT THIS DEFECT FROM RECURRING, THE BRAKE SYSTEM WILL BE CHANGED AND CAPTURED UNDER A LOCAL CHANGE CONTROL. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT RED FOREIGN MATTER WAS FOUND INSIDE 2 BD POSIFLUSH¿ SF SALINE SYRINGES DURING A WORK ORDER CREATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DISCOVERY OF RED SUBSTANCE / DEBRIS/ CONTAMINATION WITHIN 2 EACH 306553 SALINE SYRINGE 10ML LOT 2110682. OUR ASSEMBLY TEAM FOUND RED DEBRIS / CONTAMINATION WITHIN THE SYRINGE PACK AND SEAL OF 2 EACH DURING WORK ORDER CREATION. QA APPROVED THE REMAINDER OF LOT 2110682 VIA ANSI SAMPLING, NO FURTHER DEBRIS WAS FOUND, THERE IS NO MATERIAL ON HOLD.".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT RED FOREIGN MATTER WAS FOUND INSIDE 2 BD POSIFLUSH¿ SF SALINE SYRINGES DURING A WORK ORDER CREATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DISCOVERY OF RED SUBSTANCE / DEBRIS/ CONTAMINATION WITHIN 2 EACH 306553 SALINE SYRINGE 10ML LOT 2110682... OUR ASSEMBLY TEAM FOUND RED DEBRIS / CONTAMINATION WITHIN THE SYRINGE PACK AND SEAL OF 2 EACH DURING WORK ORDER CREATION. QA APPROVED THE REMAINDER OF LOT 2110682 VIA ANSI SAMPLING, NO FURTHER DEBRIS WAS FOUND, THERE IS NO MATERIAL ON HOLD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238226 BD POSIFLUSH¿ SF SALINE SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 2110682 00382903065530

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown