BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%

    MDR report key: 10613911 · Received October 1, 2020

    Report

    Report Number
    9616657-2020-00157
    Event Type
    Malfunction
    Date Received
    October 1, 2020
    Date of Event
    September 10, 2020
    Report Date
    October 14, 2020
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 9/30/2020. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 0223146 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE PHYSICAL SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLE, THE SYRINGE APPEARED CONTAMINATED WITH AN UNKNOWN RED SUBSTANCE; HOWEVER, NO SIGNS OF STOPPER SEPARATION FROM PLUNGER WERE OBSERVED. THE PLUNGER WAS PULLED BACK AND DEPRESSED WITH NO SEPARATION OR DIFFICULTIES. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS REPORTED INCIDENT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9% STOPPER SEPARATED FROM THE PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE ONCO-HAEMATOLOGY DEPARTMENT INFORMED US OF A QUALITY DISPUTE CONCERNING A BD POSIFLUSH SYRINGE. THE PLUNGER GOT DISENGAGED FROM ITS RUBBER TIP DURING RINSING OF A PICC LINE CATHETER AT THE TIME OF VENOUS RETURN CONTROL (DEFECT IN SCREWING THE PLUNGER INTO THE RUBBER?). NO CONSEQUENCES FOR THE PATIENT OR CAREGIVERS. CHANGE OF THE SYRINGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9% STOPPER SEPARATED FROM THE PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE ONCO-HAEMATOLOGY DEPARTMENT INFORMED US OF A QUALITY DISPUTE CONCERNING A BD POSIFLUSH SYRINGE. THE PLUNGER GOT DISENGAGED FROM ITS RUBBER TIP DURING RINSING OF A PICC LINE CATHETER AT THE TIME OF VENOUS RETURN CONTROL (DEFECT IN SCREWING THE PLUNGER INTO THE RUBBER?). NO CONSEQUENCES FOR THE PATIENT OR CAREGIVERS. CHANGE OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1076102 BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9% SYRINGE FMF BECTON, DICKINSON AND CO. 0223146

    Patients

    Seq Age Sex Outcome Treatment
    1 Other