BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ SYRINGE

    MDR report key: 9832601 · Received March 14, 2020

    Report

    Report Number
    1911916-2020-00247
    Event Type
    Malfunction
    Date Received
    March 14, 2020
    Date of Event
    March 5, 2020
    Report Date
    March 6, 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: NO SAMPLES OR PHOTOS WERE RECEIVED; THEREFORE, SAMPLE ANALYSIS COULD NOT BE PERFORMED AND THE CONDITION REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WHILE A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, IT IS POSSIBLE 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 # 9140782 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: WHILE A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, IT IS POSSIBLE 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 AFTER FINISHING THE PATIENT'S INFUSION, THE HANDLE OF THE BD POSIFLUSH¿ SYRINGE'S BARREL WAS FOUND DAMAGED BEFORE USING IT TO SEAL THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: AFTER THE INFUSION FOR PATIENT WAS FINISHED ON 11:30, (B)(6) 2020, THE HANDLE OF THE SYRINGE' S BARREL WAS DAMAGED BEFORE THE USING OF THE PREFILLED CATHETER IRRIGATOR TO SEAL THE TUBE, IT DIDN'T USE ON THE CHILD, AND THERE WAS NO HARMFUL EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296551 BD POSIFLUSH¿ SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 9140782

    Patients

    Seq Age Sex Outcome Treatment
    1 Other