BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE

    MDR report key: 12755337 · Received November 4, 2021

    Report

    Report Number
    9616657-2021-00090
    Event Type
    Malfunction
    Date Received
    November 4, 2021
    Date of Event
    October 8, 2021
    Report Date
    January 5, 2022
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 11/30/2021. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1132880. 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. 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 SAMPLES, FOREIGN MATTER WAS CONFIRMED ON THE PLUNGER COMPONENT AND THE PACKAGING. THE DELIVERED SAMPLE DISPLAYED STAINS ON THE OUTSIDE PORTION OF THE PACKAGING. HOWEVER, THE INTEGRITY OF THE PRODUCT AND THE STERILE BARRIERS HAVE NOT BEEN AFFECTED. THESE SPOTS APPEAR ONLY ON THE OUTSIDE OF THE PACKAGING AND DO NOT PERMEATE IN ANY WAY ONTO THE PRODUCT. FURTHERMORE, MICROBIAL PERMEABILITY TESTING, CYTOTOXICITY TESTING, AND TESTING FOR RESIDUAL SOLVENTS AND VOLATILE SPECIES HAS BEEN COMPLETED ON THE 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¿ XS 10ML SYRINGE. IN REGARDS TO THE FOREIGN MATTER ON THE PLUNGER COMPONENT, IT HAS BEEN DETERMINED THAT THE CAUSE MAY BE ASSOCIATED WITH THE MOLDING MACHINE AND ITS CLEANING PROCESS. THE FOREIGN MATTER OBSERVED ON THE PLUNGER ROD IS NOT AN ORGANIC MATERIAL AND HAS BEEN CONCLUDED AS AN ISOLATED AND INTERMITTENT 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 PRIMARY PACKAGING WAS STAINED WITH A BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: STAINS FOUND INSIDE THE PACKAGING OF BD POSIFLUSH XS SYRINGES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRIMARY PACKAGING WAS STAINED WITH A BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: STAINS FOUND INSIDE THE PACKAGING OF BD POSIFLUSH XS SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1648559 BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 1132880

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown