BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH NORMAL SALINE SYRINGE

    MDR report key: 10519170 · Received September 10, 2020

    Report

    Report Number
    2243072-2020-01395
    Event Type
    Malfunction
    Date Received
    September 10, 2020
    Date of Event
    August 21, 2020
    Report Date
    September 17, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    NGT
    UDI-DI
    30382903065463
    PMA / PMN Number
    SEE H.10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY AS NO PHYSICAL SAMPLE, PICTURE SAMPLE, OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLUNGER IN THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE WAS DIFFICULT TO DRAW BACK AND FLUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS STATED THAT SOME OF THE IV EXTENSION TUBING WERE NOT FUNCTIONING PROPERLY. IT WAS VERY DIFFICULT OR IMPOSSIBLE TO FLUSH OR DRAW BACK FROM. IT WAS REPORTED TO HAVE OCCURRED SEVERAL TIMES. THE CUSTOMER SUSPECTED THAT IT WAS NOT ALWAYS BEING CAUGHT BY THE NURSE PLACING THE LINE AS THEY SUSPECT THE VEIN WAS BAD AS OPPOSED TO THE EXTENSION TUBING BEING THE SOURCE OF THE PROBLEM WITH THE PATENCY"

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. THE CUSTOMER'S ADDRESS IS UNKNOWN. UNKNOWN, NEW JERSEY, 00000 USA HAS BEEN USED AS A DEFAULT. THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K161552. PMA / 510(K)#: K141311. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLUNGER IN THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE WAS DIFFICULT TO DRAW BACK AND FLUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS STATED THAT SOME OF THE IV EXTENSION TUBING WERE NOT FUNCTIONING PROPERLY. IT WAS VERY DIFFICULT OR IMPOSSIBLE TO FLUSH OR DRAW BACK FROM. IT WAS REPORTED TO HAVE OCCURRED SEVERAL TIMES. THE CUSTOMER SUSPECTED THAT IT WAS NOT ALWAYS BEING CAUGHT BY THE NURSE PLACING THE LINE AS THEY SUSPECT THE VEIN WAS BAD AS OPPOSED TO THE EXTENSION TUBING BEING THE SOURCE OF THE PROBLEM WITH THE PATENCY"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983746 BD POSIFLUSH NORMAL SALINE SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BECTON DICKINSON 306546 UNKNOWN 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Other