BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8758832 · Received July 3, 2019

    Report

    Report Number
    9616657-2019-00247
    Event Type
    Malfunction
    Date Received
    July 3, 2019
    Date of Event
    June 18, 2019
    Report Date
    August 5, 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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THE NON-CONFORMANCES WERE REVIEWED FOR THESE BATCHES; THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS DEFECT. IN REGARDS TO LOT 9074905: THERE WERE NO SAMPLES RECEIVED FOR THIS BATCH NUMBER. PHOTO RECEIVED DOES NOT CONFIRM BAD PERFORATION FOR THIS BATCH NUMBER REFERENCED IN THE CUSTOMER VERBATIM. THEREFORE, THE COMPLAINT FOR THIS BATCH NUMBER IS UNSUBSTANTIATED. IN REGARDS TO LOT 9050675: THE SAMPLES RECEIVED WERE REVIEWED AND VERIFIED TO HAVE BAD PERFORATION. THE ROOT CAUSE OF THIS COMPLAINT IS MAY BE ASSOCIATED WITH THE PERFORATION STATION. THERE WAS AN INTERMITTENT ISSUE DETECTED WHICH WAS INVESTIGATED AND RESOLVED WHEN REPORTED. THE BLADE MAINTENANCE PROGRAM IS CURRENTLY UNDER REVIEW WITH THE INTENTION TO DECREASE THE TIME FRAME BETWEEN BLADE REPLACEMENTS, AND THEREFORE PREVENTING POOR PERFORATION IN THE BLISTER PACKS.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USE IT WAS DISCOVERED THAT THE PACKAGES ARE DAMAGED OR PARTIALLY OPENED, THUS QUESTIONING THE STERILITY OF PRODUCT WITH A BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: REF. 306752 WITH A DEFECT WHEN CUTTING THE BLISTERS. BLISTERS TEAR THEMSELVES AWAY INSTEAD OF DETACHING THEMSELVES: STERILITY ISSUE APPROXIMATELY 300 UNITS ON LOTS 9074905 AND 9050675 ARE CONCERNED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9074905, MEDICAL DEVICE EXPIRATION DATE: 2022-02-28, DEVICE MANUFACTURE DATE: 2019-03-15, MEDICAL DEVICE LOT #: 9050675, MEDICAL DEVICE EXPIRATION DATE: 2022-01-31, DEVICE MANUFACTURE DATE: 2019-02-19." A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED PRIOR TO USE IT WAS DISCOVERED THAT THE PACKAGES ARE DAMAGED OR PARTIALLY OPENED, THUS QUESTIONING THE STERILITY OF PRODUCT WITH A BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: REF. 306752 WITH A DEFECT WHEN CUTTING THE BLISTERS. BLISTERS TEAR THEMSELVES AWAY INSTEAD OF DETACHING THEMSELVES: STERILITY ISSUE. APPROXIMATELY 300 UNITS ON LOTS 9074905 AND 9050675 ARE CONCERNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554849 BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9% PRE-FILLED SYRINGE NGT BECTON, DICKINSON AND CO. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other