BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH NORMAL SALINE SYRINGE

    MDR report key: 11202817 · Received January 20, 2021

    Report

    Report Number
    1911916-2021-00040
    Event Type
    Malfunction
    Date Received
    January 20, 2021
    Date of Event
    December 29, 2020
    Report Date
    March 12, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    30382903065463
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-02-22. INVESTIGATION SUMMARY : TO AID IN THE INVESTIGATION OF THIS ISSUE, REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH INSPECTION OF THE SAMPLES, THE PLUNGERS WERE FOUND TO EXHIBIT DIFFICULT MOVEMENT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 0223175. THE REVIEW REVEALED ONE DETECTED NON-CONFORMANCE DURING THE PRODUCTION PROCESS THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THIS INCIDENT. IT IS POSSIBLE THAT AN INTERMITTENT ISSUE WITH THE SILICON DOSAGE MACHINERY RESULTED IN THE FAULTY SYRINGES. THIS ISSUE WAS RESOLVED AT THE TIME OF OCCURRENCE, BUT IT IS POSSIBLE THAT SOME PRODUCT WAS AFFECTED PRIOR TO THE ISSUE¿S DETECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD POSIFLUSH¿ NORMAL SALINE SYRINGES HAD DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I WANTED TO REPORT A PROBLEM WE HAVE BEEN SEEING WITH THE BD SALINE FLUSHES, LOT 0223175, EXPIRATION 7-31-2023. IT HAS HAPPENED THREE TIMES THIS WEEK WHERE WE ENCOUNTER A LOT OF RESISTANCE (MORE LIKE A BLOCK; THE PLUNGER WOULD NOT GO FURTHER) AS WE ARE FLUSHING AN IV LINE. THE RESISTANCE/BLOCKAGE WAS STILL THERE WHEN IT WAS NOT ATTACHED TO AN IV. USING A LOT OF FORCE, IT WILL MOVE FORWARD. JUST THOUGHT WE WOULD LET YOU KNOW. OCCURRED AROUND DEC 9TH. REPORTED TO BD: 12/29".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. 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 3 BD POSIFLUSH¿ NORMAL SALINE SYRINGES HAD DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I WANTED TO REPORT A PROBLEM WE HAVE BEEN SEEING WITH THE BD SALINE FLUSHES, LOT 0223175, EXPIRATION 7-31-2023. IT HAS HAPPENED THREE TIMES THIS WEEK WHERE WE ENCOUNTER A LOT OF RESISTANCE (MORE LIKE A BLOCK; THE PLUNGER WOULD NOT GO FURTHER) AS WE ARE FLUSHING AN IV LINE. THE RESISTANCE/BLOCKAGE WAS STILL THERE WHEN IT WAS NOT ATTACHED TO AN IV. USING A LOT OF FORCE, IT WILL MOVE FORWARD. JUST THOUGHT WE WOULD LET YOU KNOW. OCCURRED AROUND (B)(6). REPORTED TO BD: 12/29".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97915 BD POSIFLUSH NORMAL SALINE SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 306546 0223175 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1