BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE

    MDR report key: 13003600 · Received December 14, 2021

    Report

    Report Number
    1911916-2021-01259
    Event Type
    Malfunction
    Date Received
    December 14, 2021
    Date of Event
    November 16, 2021
    Report Date
    November 30, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    30382903065470
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: IT WAS REPORTED THE SYRINGE APPEARED TO HAVE SEDIMENT. TO AID IN THE INVESTIGATION, ONE SAMPLE IN A PLASTIC BAG WITH 6ML OF SOLUTION AND NO TIP CAP WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED WITH A 10X MAGNIFIER LENS AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. ADDITIONALLY, WITH THE SAMPLE IN ANOTHER PLASTIC BAG, CAME A 1ML SYRINGE WITH THE PLUNGER ROD DISASSEMBLED. THE SYRINGE BARREL IS CONNECTED TO A THREE WAY CONNECTOR PORT AND TUBE. NONE OF THESE ADDITIONAL UNITS ARE PRODUCED BY THIS SITE, OR ARE RELATED TO THE COMPLAINT REPORTED BY THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 30654778, LOT NUMBER 1133437. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED AND A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN SEDIMENT WAS FOUND IN THE BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RN ASSESSING MEDICATION LINE ATTACHED TO PICC LINE. NOTED WHAT SHE THOUGHT WERE BUBBLES IN 0.9 NACL SYRINGE, UPON FURTHER INSPECTION BUBBLES APPEAR TO BE SEDIMENT IN THE SYRINGE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1895897 BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 306547 1133437 30382903065470

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown