BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH-XS / SF

    MDR report key: 19499017 · Received June 10, 2024

    Report

    Report Number
    9616657-2024-00018
    Event Type
    Malfunction
    Date Received
    June 10, 2024
    Date of Event
    May 14, 2024
    Report Date
    June 13, 2024
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    00382903065721
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ADDITIONAL LOT NUMBERS WERE PROVIDED IN THIS COMPLAINT FOR MATERIAL NUMBER 306572. LOT # 3250005 MFG: 2023-09-07 EXP: 2026-08-31 LOT # 3320906 MFG: 2023-11-16 EXP: 2026-10-31 INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306572 AND LOT NUMBERS 3250005, 3320906, AND 3114159. THE REVIEW DID NOT REVEAL ANY DETECTED NON-CONFORMANCES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, TWO (2) PICTURES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE PICTURE SAMPLES WERE SUFFICIENT IN CONFIRMING THE BROWN SPOTTING/STAINING ON THE OUTSIDE OF THE BLISTER PACKAGE. THE BROWNISH SPOTS ON THE PACKAGING WERE CREATED DURING THE STEAM STERILIZATION PROCESS. THE INTEGRITY OF THE PRODUCT AND THE STERILE BARRIERS DID NOT APPEAR TO HAVE BEEN AFFECTED. FURTHERMORE, MICROBIAL PERMEABILITY TESTING, CYTOTOXICITY TESTING, AND TESTING FOR RESIDUAL SOLVENTS AND VOLATILE SPECIES HAS BEEN COMPLETED ON PACKAGES DISPLAYING THE BROWNISH STAIN. THE TESTING CONFIRMED THAT THEY DO NOT PRESENT ANY RISK TO THE USE OF THE PRODUCT AND HAVE NO IMPACT ON THE EFFECTIVENESS, STERILITY, QUALITY, OR SAFETY OF BD POSIFLUSH¿ 10ML SALINE FLUSH SYRINGE. REPORTS FOR THIS EVENT WILL CONTINUE TO BE MONITORED, TRACKED, AND TRENDED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306572 AND LOT NUMBERS 3250005, 3320906, AND 3114159. THE REVIEW DID NOT REVEAL ANY DETECTED NON-CONFORMANCES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, TWO (2) PICTURES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE PICTURE SAMPLES WERE SUFFICIENT IN CONFIRMING THE BROWN SPOTTING/STAINING ON THE OUTSIDE OF THE BLISTER PACKAGE. THE BROWNISH SPOTS ON THE PACKAGING WERE CREATED DURING THE STEAM STERILIZATION PROCESS. THE INTEGRITY OF THE PRODUCT AND THE STERILE BARRIERS DID NOT APPEAR TO HAVE BEEN AFFECTED. FURTHERMORE, MICROBIAL PERMEABILITY TESTING, CYTOTOXICITY TESTING, AND TESTING FOR RESIDUAL SOLVENTS AND VOLATILE SPECIES HAS BEEN COMPLETED ON PACKAGES DISPLAYING THE BROWNISH STAIN. THE TESTING CONFIRMED THAT THEY DO NOT PRESENT ANY RISK TO THE USE OF THE PRODUCT AND HAVE NO IMPACT ON THE EFFECTIVENESS, STERILITY, QUALITY, OR SAFETY OF BD POSIFLUSH¿ 10ML SALINE FLUSH SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PRE-FILLED SYRINGES POSIFLUSH-XS / SF HAD FOREIGN MATTER/SPOTS THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: WHEN DID THE INCIDENT OCCUR? BEFORE USE THE CUSTOMER NOTICED IN SEVERAL UNITS OF THE LOTS LISTED SOME BROWN SPOT/STAIN ON THE BLISTER (PAPER PART). HE USED THE PRODUCT ANYWAY BECAUSE HE CHECKED THE INTEGRITY OF THE BLISTER UNIT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653437 BD POSIFLUSH-XS / SF SALINE VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 3114159 00382903065721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown