BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ SYRINGE

    MDR report key: 9881423 · Received March 25, 2020

    Report

    Report Number
    1911916-2020-00305
    Event Type
    Malfunction
    Date Received
    March 25, 2020
    Date of Event
    March 17, 2020
    Report Date
    March 20, 2020
    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: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. IT COULD HAVE HAPPENED THAT A JAM OCCURRED AT THE PLUNGER ROD ASSEMBLY PROCESS INDUCING DAMAGES TO THE BARREL. 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. 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: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. THIS IS THE 1ST COMPLAINT FOR LOT # 9112675 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. ROOT CAUSE DESCRIPTION: POSIFLUSH ASSEMBLY LINE. PLUNGER ROD ASSEMBLY. IT COULD HAVE HAPPENED THAT A JAM OCCURRED AT THE PLUNGER ROD ASSEMBLY PROCESS INDUCING DAMAGES TO THE BARREL. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ SYRINGE BARREL WAS FOUND DAMAGED BEFORE USE. AFTER REMOVING T FROM THE PACKAGING AND USING THE SYRINGE TO INJECT, IT "SCRATCHED" THE NURSE'S HAND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "WHEN THE NURSE USED A PRE-FILLED CATHETER FLUSHER TO INDWELL THE NEEDLE TO SEAL THE TUBE, THE PACKAGE WAS UNPACKED AND THE APPEARANCE OF THE SYRINGE WAS DAMAGED. IT WAS DIFFICULT FOR THE NURSE TO FIX AND SCRATCH THE SKIN OF THE HAND WHEN INJECTING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345214 BD POSIFLUSH¿ SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 9112675

    Patients

    Seq Age Sex Outcome Treatment
    1 Other