BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH NORMAL SALINE SYRINGE

    MDR report key: 11286428 · Received February 5, 2021

    Report

    Report Number
    1911916-2021-00096
    Event Type
    Malfunction
    Date Received
    February 5, 2021
    Date of Event
    January 12, 2021
    Report Date
    January 28, 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
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 223825. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS INCIDENT, FOUR SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLES CAME WITH NO SALINE SOLUTION AND WITH THE PLUNGER ROD- RUBBER STOPPER ALL THE WAY DOWN. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THEN, EACH SAMPLE WAS TESTED FOR SUSTAINING FORCE AND THE RESULTS WERE WITHIN SPECIFICATION. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. ROOT CAUSE DESCRIPTION: THE CAUSE FOR THIS DEFECT COULD HAVE RESULTED IF THE CUSTOMER NOTICED THAT MORE THAN USUAL FORCE WAS REQUIRED TO EXPEL THE SOLUTION, AS ONE OF THE SAMPLES FORCE RESULT WAS TOWARDS THE HIGH SPECIFICATION LIMIT. RATIONALE: FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE MANUFACTURING PROCESS FOR THIS DEFECT AND OTHER EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE PLUNGER WAS DIFFICULT TO PUSH AFTER "5 ML" HAD BEEN INJECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "10 ML 0.9% SALINE SYRINGES BECOME VERY DIFFICULT TO PUSH AFTER 5 ML HAS BEEN INJECTED. INITIALLY, WE THOUGHT IT WAS AN IV ISSUE, BUT WE HAVE HAD SEVERAL SYRINGES FROM THE SAME LOT THAT WE'VE HAD AN ISSUE WITH. IT HAS BEEN REPORTED THIS HAS HAPPENED ON MULTIPLE OCCASIONS AND IT HAS HAPPENED WITH FLUSHES FROM DIFFERENT BOXES. THE FIRST FEW TIMES IT WAS THOUGHT TO BE AN IV ISSUE. IV TUBING INFORMATION: THEY USE BD SAF-T-INTIMAS BUT WE HAVE HAD THIS ISSUE WITH PATIENTS THAT HAVE ANGIOCATHS AS WELL"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181032 BD POSIFLUSH NORMAL SALINE SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 306546 0223825 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1