BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%

    MDR report key: 10418164 · Received August 17, 2020

    Report

    Report Number
    9616657-2020-00125
    Event Type
    Malfunction
    Date Received
    August 17, 2020
    Date of Event
    July 27, 2020
    Report Date
    August 26, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBERS 0111366, 0105650, 0035110, AND 9263969. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, EIGHT PICTURE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURES, BROWN STAINS WERE OBSERVED ON THE PRODUCT PACKAGING. IT HAS BEEN DETERMINED THAT THE STAINS RESULTED FROM 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¿ XS 10ML SALINE FLUSH SYRINGE. WE ARE CURRENTLY EXPLORING SEVERAL OPTIONS TO REDUCE AND ELIMINATE ANY BROWN STAINING THAT OCCURS ON THE PACKAGING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRIMARY PACKAGING OF THE BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9% WAS FOUND STAINED. THERE WERE 210 SYRINGES IN LOT 9263969, 132 SYRINGES IN LOT 0035110, 133 SYRINGES IN LOT 0105650, AND 196 SYRINGES IN LOT 0111366 FOUND WITH THIS DEFECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STAINS ON THE PACKAGING."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9263969, MEDICAL DEVICE EXPIRATION DATE: 2022-08-31, DEVICE MANUFACTURE DATE: 2019-09-20, MEDICAL DEVICE LOT #: 0035110, MEDICAL DEVICE EXPIRATION DATE: 2023-01-31, DEVICE MANUFACTURE DATE: 2020-02-04, MEDICAL DEVICE LOT #: 0105650, MEDICAL DEVICE EXPIRATION DATE: 2023-03-31, DEVICE MANUFACTURE DATE: 2020-04-14, MEDICAL DEVICE LOT #: 0111366, MEDICAL DEVICE EXPIRATION DATE: 2023-03-31, DEVICE MANUFACTURE DATE: 2020-04-20. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRIMARY PACKAGING OF THE BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9% WAS FOUND STAINED. THERE WERE 210 SYRINGES IN LOT 9263969, 132 SYRINGES IN LOT 0035110, 133 SYRINGES IN LOT 0105650, AND 196 SYRINGES IN LOT 0111366 FOUND WITH THIS DEFECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STAINS ON THE PACKAGING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876527 BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9% SALINE VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other