BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ SYRINGE

    MDR report key: 9554100 · Received January 6, 2020

    Report

    Report Number
    1911916-2019-01369
    Event Type
    Malfunction
    Date Received
    January 6, 2020
    Date of Event
    December 20, 2019
    Report Date
    December 27, 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
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY SEVENTEEN SAMPLES AND 4 PHOTOS WERE RECEIVED FOR EVALUATION. THEY HAVE PLUNGER ROD-RUBBER STOPPER, NO TIP CAP, NO SALINE SOLUTION. THE PLUNGER ROD- RUBBER STOPPERS ARE ALL THE WAY DOWN. THREE OUT OF THE FOUR HAVE THE BARREL FLANGE DAMAGED. ONE OF THE FOUR HAVE THE BARREL FLANGE AND THE THUMB PRESS DAMAGED. THE REST ARE 14 SAMPLES THAT ARE IN THE SEALED PACKAGING FLOW WRAP. THEY ALL HAVE THE BARREL FLANGE DAMAGED. THE PHOTOS PROVIDED SHOW SYRINGES WITH THE BARREL FLANGE DAMAGED. THIS TYPE OF DAMAGE MAY HAVE OCCURRED AT THE PLUNGER ROD ASSEMBLY PROCESS. A MISALIGNMENT AT THE INFEED STATION COULD HAVE INDUCED THIS DAMAGE AND NOT BEEN NOTICED DURING THE PACKAGING PROCESS. 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. INVESTIGATION CONCLUSION: THIS IS THE 1ST COMPLAINT FOR LOT # 9112900 FOR THIS TYPE OF DEFECT OR SYMPTOM. 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. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. ROOT CAUSE DESCRIPTION: THIS TYPE OF DAMAGE MAY HAVE OCCURRED AT THE PLUNGER ROD ASSEMBLY PROCESS. A MISALIGNMENT AT THE INFEED STATION COULD HAVE INDUCED THIS DAMAGE AND NOT BEEN NOTICED DURING THE PACKAGING PROCESS. RATIONALE CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD POSIFLUSH¿ SYRINGE THERE WAS AN ISSUE WITH DAMAGE PRODUCT. DAMAGE CAN BE SEEN IN SOME PACKAGES BEFORE OPENING AND OTHER DAMAGE IS FOUND UPON OPENING PACKAGE. 17 UNIT HAD THE ISSUE WITH DAMAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE PLUNGER ROD AND THE FLANGE OF THE SYRINGE BARREL HAS DIFFERENT DEGREE OF DAMAGE. PART OF IT WAS FOUND WHEN OPENED THE PACKAGE; PART OF IT IS SEEN BEFORE THE PACKAGE IS OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19082 BD POSIFLUSH¿ SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 9112900

    Patients

    Seq Age Sex Outcome Treatment
    1 Other