BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL

    MDR report key: 11742395 · Received April 28, 2021

    Report

    Report Number
    1911916-2021-00386
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    March 31, 2021
    Report Date
    April 16, 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
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: IT WAS REPORTED THAT THE SYRINGE WOULD NOT FLUSH OR ASPIRATE. TO AID IN THE INVESTIGATION, ONE SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLE CAME WITH NO PACKAGING FLOW WRAP, OR TIP CAP AND THE RUBBER STOPPER IS AT THE 10ML MARK IN THE GRADUATION SCALE. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE SAMPLE WAS THEN TESTED FOR SUSTAINING FORCE, WHICH IS THE FORCE APPLIED TO THE PLUNGER ROD WHILE MOVING DOWNWARDS WHEN EXPELLING THE SALINE SOLUTION, AND THE RESULT WAS WITHIN SPECIFICATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDE MATERIAL NUMBER 306547, LOT NUMBER 0231392. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE EXPERIENCE OF OUR PROCESSES, THE EFFECT OF HAVING PLUNGER RESISTANCE COULD BE INDUCED BY HOW THE SILICONE IS APPLIED TO THE SYRINGE BARREL INNER WALL. WE HAVE INITIATIVES IN OUR PRODUCTION LINE MONITORING THE SILICONE APPLICATION AND ITS CONSISTENCY. BASED ON THE INVESTIGATION 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 · 1

    IT WAS REPORTED THAT THE SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL HAD DIFFICULT PLUNGER MOVEMENT AND WOULD NOT FLUSH NOR ASPIRATE DURING A DEMONSTRATION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NURSE ATTACHED THE POSI-FLUSH DEVICE (REF 306547, LOT 0231392) TO A STANDALONE SS (2000E, LOT #21025158) TO FLUSH BUT COULD NEITHER FLUSH NOR ASPIRATE. THE SS WAS OCCLUDED. THERE WAS NO PATIENT RISK SINCE THE DEVICE WAS NOT USED ON A PATIENT. IT WAS USED FOR DEMONSTRATION PURPOSES ONLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633967 SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL SALINE VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 306547 0231392 30382903065470

    Patients

    Seq Age Sex Outcome Treatment
    1