BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9%

    MDR report key: 8846621 · Received July 31, 2019

    Report

    Report Number
    1911916-2019-00752
    Event Type
    Malfunction
    Date Received
    July 31, 2019
    Date of Event
    July 16, 2019
    Report Date
    July 18, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE SAMPLE WAS RECEIVED FOR EVALUATION. THE PLUNGER ROD IS NOT ASSEMBLED TO THE STOPPER. ADDITIONALLY, ONE PHOTO WAS PROVIDED. IT SHOWS THE PLUNGER ROD DISCONNECTED TO THE RUBBER STOPPER. AT THE PLUNGER ROD ASSEMBLY MACHINE, WE HAVE A SENSOR VERIFYING THE PLUNGER ROD-STOPPER SEPARATION. THE SAMPLE WITH THE DISCONNECTED PLUNGER ROD WAS TAKEN TO THE PRODUCTION LINE. IT WAS REJECTED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. THIS IS THE 1ST COMPLAINT FOR THE LOT# 8201693 FOR THE SAME DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH 8201693 DURING THE PRODUCTION RUN. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE WITH THE SAMPLE PROVIDED. ROOT CAUSE DESCRIPTION: WHILE THE FAILURE MODE WAS VERIFIED, ROOT CAUSE COULD NOT BE DETERMINED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9% STOPPER WAS DEFECTIVE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE STOPPER BROKEN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641745 BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9% SALINE VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 8201693

    Patients

    Seq Age Sex Outcome Treatment
    1 Other