BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ POSIFLUSH¿ SALINE XS 10 ML

    MDR report key: 17258462 · Received July 5, 2023

    Report

    Report Number
    9616657-2023-00016
    Event Type
    Malfunction
    Date Received
    July 5, 2023
    Date of Event
    June 9, 2023
    Report Date
    July 21, 2023
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    00382903065721
    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

    D10: DEVICE AVAILABLE FOR EVAL YES . D10: RETURNED TO MANUFACTURER ON: 19JUL2023. 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. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) SYRINGE WAS RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE SYRINGE, INCORRECT FILL WAS IDENTIFIED. AN AIR LEAK TEST WAS PERFORMED ON THE SYRINGE BARREL AND THE RESULTS SHOWED A FAILURE. VISUAL INSPECTION OF THE BARREL CONFIRMED A SINK IN THE LUER COMPONENT. A SERVICE WAS PREVIOUSLY COMPLETED ON THE APPLICABLE MOLD COMPONENT. A CURRENT SAMPLE WAS OBTAINED FROM THIS MOLD COMPONENT FOR ANALYSIS. THE CURRENT SAMPLE WAS FOUND TO PASS THE AIR LEAK TEST. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    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¿ SALINE XS 10 ML THE PREFILLED SYRINGE HAD THE INCORRECT VOLUME. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: POSIFLUSH10ML 0.9% NACL PREFILLED SYRINGE WAS REMOVED FROM IT'S SEALED PACKAGING JUST PRIOR TO USE. THE SYRINGE SHOULD HAVE BEEN PREFILLED WITH 10ML OF NACL BUT WAS FOUND TO HAVE JUST UNDER 1ML OF NACL IN IT WITH THE REMAINDER BEING AIR.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD¿ POSIFLUSH¿ SALINE XS 10 ML THE PREFILLED SYRINGE HAD THE INCORRECT VOLUME. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: POSIFLUSH10ML (B)(4) NACL PREFILLED SYRINGE WAS REMOVED FROM IT'S SEALED PACKAGING JUST PRIOR TO USE. THE SYRINGE SHOULD HAVE BEEN PREFILLED WITH 10ML OF NACL BUT WAS FOUND TO HAVE JUST UNDER 1ML OF NACL IN IT WITH THE REMAINDER BEING AIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1931468 BD¿ POSIFLUSH¿ SALINE XS 10 ML SALINE, VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 3061553 00382903065721

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown