BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGES

    MDR report key: 17703138 · Received September 7, 2023

    Report

    Report Number
    1911916-2023-00635
    Event Type
    Malfunction
    Date Received
    September 7, 2023
    Date of Event
    August 18, 2023
    Report Date
    September 12, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    30382903065463
    PMA / PMN Number
    K003553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 306546 AND LOT NUMBER 3142760. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD POSIFLUSH¿ NORMAL SALINE SYRINGES THE PLUNGER MOVEMENT WAS DIFFICULT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE MULTIPLE COMPLAINTS OF THE 306546 FLUSHES REQUIRING EXCESSIVE PRESSURE (BOTH MANUAL PRESSURE AND/OR SYRINGE PUMP PRESSURE) TO PLUNGE. WE HAVE PULLED ALL OF LOT #3142760.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD POSIFLUSH¿ NORMAL SALINE SYRINGES THE PLUNGER MOVEMENT WAS DIFFICULT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE MULTIPLE COMPLAINTS OF THE 306546 FLUSHES REQUIRING EXCESSIVE PRESSURE (BOTH MANUAL PRESSURE AND/OR SYRINGE PUMP PRESSURE) TO PLUNGE. WE HAVE PULLED ALL OF LOT #3142760.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2090525 BD POSIFLUSH¿ NORMAL SALINE SYRINGES SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 3142760 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown