BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML SALINE XS

    MDR report key: 12536415 · Received September 27, 2021

    Report

    Report Number
    9616657-2021-00085
    Event Type
    Malfunction
    Date Received
    September 27, 2021
    Date of Event
    August 16, 2021
    Report Date
    October 1, 2021
    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

    H.6. INVESTIGATION: TO AID IN THE INVESTIGATION OF THIS ISSUE, PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE RETURNED SAMPLES, BROWN STAINS WERE OBSERVED ON THE OUTER PRODUCT PACKAGING. THE BROWN STAINS WERE MOST LIKELY CREATED DURING THE STEAM STERILIZATION PROCESS. 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¿ SF 10ML SALINE FLUSH SYRINGE. DHR WAS PERFORMED. THE NON-CONFORMANCES WERE REVIEWED FOR THIS BATCH AND THERE WAS NO RECORD OF NON-CONFORMANCE ASSOCIATED WITH THIS BATCH. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 10ML SALINE XS HAD STAINS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MEDICAL DEVICE CONCERNED: SODIUM CHLORIDE DEVICE 0.9% 10ML BD SALINE POSIFLUSH XS SOL RINCAGE SRG LL. DATE OF INCIDENT: 16/AUGUST/2021. NUMBER OF UNITS AFFECTED: 1. THE OUTER AND INNER PACKAGING OF THE SYRINGES SHOW "RED-BROWN" STAINS. PROBLEM DETECTED AT THE PUI AND ENCOUNTERED IN ALL THE UNITS OF THE BOX. DEVICES QUARANTINED DUE TO FEAR OF POOR STORAGE CONDITIONS. NO PATIENTS CONCERNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 10ML SALINE XS HAD STAINS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MEDICAL DEVICE CONCERNED: SODIUM CHLORIDE DEVICE 0.9% 10ML BD SALINE POSIFLUSH XS SOL RINCAGE SRG LL DATE OF INCIDENT: (B)(6) 2021 NUMBER OF UNITS AFFECTED: 1 THE OUTER AND INNER PACKAGING OF THE SYRINGES SHOW "RED-BROWN" STAINS. PROBLEM DETECTED AT THE PUI AND ENCOUNTERED IN ALL THE UNITS OF THE BOX. DEVICES QUARANTINED DUE TO FEAR OF POOR STORAGE CONDITIONS. NO PATIENTS CONCERNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428779 SYRINGE 10ML SALINE XS SYRINGE FMF BECTON, DICKINSON AND CO. 1139773

    Patients

    Seq Age Sex Outcome Treatment
    1