BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 17715348 · Received September 8, 2023

    Report

    Report Number
    9616657-2023-00037
    Event Type
    Malfunction
    Date Received
    September 8, 2023
    Date of Event
    August 23, 2023
    Report Date
    October 9, 2023
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306572 AND LOT NUMBER 3061553. THE REVIEW DID NOT REVEAL ANY NON-CONFORMANCES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. AS NEITHER PICTURE SAMPLES NOR PHYSICAL SAMPLES WERE AVAILABLE, A THOROUGH SAMPLE ANALYSIS COULD NOT BE COMPLETED. THIS IS THE FIRST REPORT WE HAVE RECEIVED FOR THIS TYPE OF DEFECT. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E.1. INITIAL REPORTER PHONE #: (B)(6). H3. 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 · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE HAD A HOLE IN IT. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: PATIENT WAS ABOUT TO FLUSH THE LINE AFTER THE INFUSION. THE PATIENT NOTICED THAT THE PACKAGING OF THE POSIFLUSH HAD A HOLE IN IT AND THIS HAD BEEN COVERED IT/REPAIRED WITH A PIECE OF STICKY TAPE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE HAD A HOLE IN IT. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: PATIENT WAS ABOUT TO FLUSH THE LINE AFTER THE INFUSION. THE PATIENT NOTICED THAT THE PACKAGING OF THE POSIFLUSH HAD A HOLE IN IT AND THIS HAD BEEN COVERED IT/REPAIRED WITH A PIECE OF STICKY TAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614831 BD POSIFLUSH¿ NORMAL SALINE SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 3061553

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown