BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8897630 · Received August 15, 2019

    Report

    Report Number
    9616657-2019-00313
    Event Type
    Malfunction
    Date Received
    August 15, 2019
    Date of Event
    July 31, 2019
    Report Date
    September 17, 2019
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF LEAKAGE OTHER WITH LOT #8242797 REGARDING ITEM #306572. THE DHR REVIEW SHOWED THAT THERE WAS A RECORD OF NON-CONFORMANCE ASSOCIATED WITH THIS BATCH. THE BD COULD NOT VERIFY LEAKAGE, HOWEVER THE TOP WEB (PAPER) OF THE PACKAGE CONFIRMS WATER DAMAGE. THERE WAS AN INTERMITTENT ISSUE WITH WORN/DAMAGED PART ON THE BARREL MOULD MACHINE. PRODUCT ASSOCIATED WITH THE DEFECT WAS HELD FOR INSPECTION, AND THE AFFECTED MATERIAL WAS SCRAPPED. IT IS POSSIBLE THAT THE ISSUE MAY HAVE BEEN INTERMITTENT PRIOR TO DETECTION AND THERE MAY HAVE BEEN A LIMITED OCCURRENCE OUTSIDE THE CONTAINED MATERIAL. THE ISSUE WAS RESOLVED BY INSERTING NEW PART WITHIN THE MOULD MACHINE. BARREL SAMPLES WERE SUBMITTED FOR INSPECTION AFTER NEW PART WAS FITTED AND PASSED. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "DROPS OF WATER" WERE NOTICED ON THE BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9% BAG SURFACE, AND LEAKAGE WAS FOUND COMING FROM THE SYRINGE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: WHEN INTEGRATING ONE OF THEIR KITS CONTAINING SEVERAL MEDICAL DEVICES, DROPS OF WATER ARE OBSERVED ON THE SURFACE OF THE BAG, THE CORRESPONDING INVESTIGATION IS CARRIED OUT WHERE LEAKAGE IS DETECTED IN THE 10 ML POSIFLUSH SYRINGE LOT 8242797 BD BRAND.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 · 1

    IT WAS REPORTED THAT "DROPS OF WATER" WERE NOTICED ON THE BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9% BAG SURFACE, AND LEAKAGE WAS FOUND COMING FROM THE SYRINGE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: WHEN INTEGRATING ONE OF THEIR KITS CONTAINING SEVERAL MEDICAL DEVICES, DROPS OF WATER ARE OBSERVED ON THE SURFACE OF THE BAG, THE CORRESPONDING INVESTIGATION IS CARRIED OUT WHERE LEAKAGE IS DETECTED IN THE 10 ML POSIFLUSH SYRINGE LOT 8242797 BD BRAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693682 BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9% SALINE VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 8242797

    Patients

    Seq Age Sex Outcome Treatment
    1 Other