BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV-SET P 180 CM PVC STOPCOCK L-L

    MDR report key: 8380163 · Received February 28, 2019

    Report

    Report Number
    2243072-2019-00353
    Event Type
    Malfunction
    Date Received
    February 28, 2019
    Date of Event
    February 6, 2019
    Report Date
    April 30, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1010962. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY THE DEVICE WAS SUBJECTED TO LEAKAGE TESTING, THE RESULTS FOUND THE DEVICE TO OPERATING AS EXPECTED, UNDER PRODUCT SPECIFICATION. UNFORTUNATELY BASED ON OUR FINDINGS, THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED AT THE CONCLUSION OF OUR REVIEW. 6 SAMPLES RECEIVED ON SITE FOR INVESTIGATION 5 OF THEM IN ORIGINAL PACKAGING AND ONE WITH SYRINGE STILL ATTACHED TO IT DECONTAMINATED FROM NELSON LABS. TESTING WAS CONDUCTED ON ALL 6 SAMPLES RECEIVED FROM THE AFFECTED LOT. FUNCTIONAL TEST PASSED 5 UNOPENED SAMPLES. SAMPLE THAT CAME OPENED DID NOT PASS FUNCTIONAL TEST. COSTUMER DESCRIPTION WHEN USING SYRINGE LEAKAGE WAS OBSERVED ON UPPER INJECTING PORTION OF EXTENSION WHICH WAS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A IV-SET P 180 CM PVC STOPCOCK L-L HAD LEAKAGE AT THE INJECTION PORT DESPITE CLOSURE FLAP BEING CLOSED. THE REPORT IS AS FOLLOWS, "INJECTION PORT IN EXTENSION IS LEAKING. DESPITE THE CLOSURE FLAP BEING CLOSED, LIQUID ESCAPES OCCUR DURING APPLICATION."

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. THE REPORTED LOT# 1010962 WAS NOT FOUND FOR THE CATALOG NUMBER PROVIDED. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A IV-SET P 180 CM PVC STOPCOCK L-L HAD LEAKAGE AT THE INJECTION PORT DESPITE CLOSURE FLAP BEING CLOSED. THE REPORT IS AS FOLLOWS, "INJECTION PORT IN EXTENSION IS LEAKING. DESPITE THE CLOSURE FLAP BEING CLOSED, LIQUID ESCAPES OCCUR DURING APPLICATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170021 IV-SET P 180 CM PVC STOPCOCK L-L STOPCOCK FMG BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other