BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE

    MDR report key: 15873359 · Received November 28, 2022

    Report

    Report Number
    9616657-2022-00045
    Event Type
    Malfunction
    Date Received
    November 28, 2022
    Date of Event
    November 2, 2022
    Report Date
    December 23, 2022
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 2222577. 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. AS NEITHER A PICTURE SAMPLE NOR A PHYSICAL SAMPLE WAS AVAILABLE FOR RETURN, A THOROUGH SAMPLE ANALYSIS COULD NOT BE PERFORMED. BASED ON THE LIMITED INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED INCIDENT.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE HAD BLOOD COMING OUT THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THE DIALYSIS SERVICE TELLS US THAT "BLOOD IS COMING OUT OF THE PLUNGER", AND THIS HAS HAPPENED IN LOT 2222577.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE HAD BLOOD COMING OUT THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THE DIALYSIS SERVICE TELLS US THAT "BLOOD IS COMING OUT OF THE PLUNGER", AND THIS HAS HAPPENED IN LOT 2222577.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1947250 BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE PISTON SYRINGE FMF BECTON, DICKINSON AND CO. 2222577

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown