BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%

    MDR report key: 13259703 · Received January 14, 2022

    Report

    Report Number
    9616657-2021-00097
    Event Type
    Malfunction
    Date Received
    January 14, 2022
    Date of Event
    December 21, 2021
    Report Date
    February 8, 2022
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2022-01-17. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1203643. 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. ALL RELEVANT IN PROCESS AND FINISHED PRODUCT INSPECTIONS WERE PERFORMED AND DETERMINED THAT THE PRODUCT WAS FIT FOR ITS INTENDED USE AND MET STANDARD REQUIREMENTS. TO AID IN THE INVESTIGATION OF THIS ISSUE, BOTH PICTURE AND PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURE SAMPLES, IT CANNOT BE CONFIRMED WHETHER THE OBSERVED DEFECT IS PRESENT ON THE LABEL, BARREL, OR WITHIN THE SOLUTION. THE TWO PHYSICAL SAMPLES RETURNED DID NOT PRESENT THE DESCRIBED DEFECT. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS REPORTED ISSUE. THIS IS THE FIRST REPORT RECEIVED FOR THIS TYPE OF DEFECT ON MATERIAL 306572 AND LOT NUMBER 1203643. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "CUSTOMER DESCRIPTION ON THE PHONE: CONTAMINATION IN THE SYRINGE CHAMBER - AS IF SOMETHING IS "GROWING" - HE WILL SEND PHOTOS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "CUSTOMER DESCRIPTION ON THE PHONE: CONTAMINATION IN THE SYRINGE CHAMBER - AS IF SOMETHING IS "GROWING" - HE WILL SEND PHOTOS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807760 BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9% SALINE VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 1203643

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown