BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH

    MDR report key: 20257122 · Received September 19, 2024

    Report

    Report Number
    9616657-2024-00026
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    August 15, 2024
    Report Date
    January 14, 2025
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    00382903065721
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E1. ADDRESS INFORMATION WAS NOT PROVIDED, THEREFORE, XX WAS USED AS A PLACE HOLDER.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306572 AND LOT NUMBER 4043303. THE REVIEW DID NOT REVEAL ANY NON-CONFORMANCES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) PICTURE SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PICTURE, LEAKAGE WAS OBSERVED PAST THE STOPPER COMPONENT. BASED ON THE PROVIDED FEEDBACK AND THE INVESTIGATION CONCLUSIONS, IT WAS DETERMINED THAT THIS INCIDENT RESULTED FROM CUSTOMER MISUSE. POSIFLUSH SYRINGES ARE PRE-FILLED SINGLE USE SYRINGES, INTENDED FOR FLUSHING. PREFILLED AND CONVENTIONAL SYRINGES HAVE DIFFERENT PURPOSES. WE RECOMMEND REACHING OUT TO YOUR BD SALES OR MARKETING CONTACT FOR ADDITIONAL ASSISTANCE. 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

    ADDITIONAL INFORMATION: PATIENT OUTCOME INFORMATION RECEIVED. ANNEX E/F CODES UPDATED. MATERIAL/LOT NUMBER INFORMATION RECEIVED. POPULATED AND MFG/EXP DATES APPLIED. UDI POPULATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD POSIFLUSH LEAKED PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE PRIMING OF THE CATHETER FOR HEMODIALYSIS, THERE WAS A BLOOD LEAK AROUND THE PLUNGER OF TWO PREFILLED BD POSILFUSH XS SYRINGES SF.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    MATERIAL#: 306572; BATCH#: 4043303. IT WAS REPORTED BY THE CUSTOMER THAT DURING THE PRIMING OF THE CATHETHER FOR HEMODIALYSIS, THERE WAS A BLOOD LEAK AROUND THE PLUNGER OF TWO PREFILLED BD POSILFUSH XS SYRINGES SF. ADDITIONAL INFO (25-SEPT-2024). 1. WHAT IMPACT DID THIS INCIDENT HAVE ON THE PATIENT? THIS INCIDENT DID NOT HAVE AN IMMEDIATE IMPACT ON THE PATIENT, BUT THE STERILITY OF THE PRODUCT IS COMPROMISED, WHICH INCREASES THE RISK OF INFECTIONS IN THE CENTRAL LINE. 2. DID THE INCIDENT RESULT IN ANY ADVERSE CONSEQUENCES OR SERIOUS HARM TO A PATIENT OR HEALTH CARE WORKER? NO IF YES, PLEASE PROVIDE THE DETAILS. 3. PLEASE LET US KNOW THE EXACT DATE THE INCIDENT OCCURRED (IN DD-MM-YYYY FORMAT). (B)(6) 2024. 4. HOW MANY TIMES HAS THE REPORTED INCIDENT OCCURRED? THIS HAS BEEN REPORTED A FEW TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1786437 BD POSIFLUSH SALINE VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 4043303 00382903065721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown