BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II 20GAX1.16IN PRN SLM NPVC

    MDR report key: 9070225 · Received September 16, 2019

    Report

    Report Number
    3006948883-2019-00758
    Event Type
    Malfunction
    Date Received
    September 16, 2019
    Date of Event
    August 31, 2019
    Report Date
    October 28, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    FPA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8141349. 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. ALSO, WITH THE SAMPLES PROVIDED TO US, OUR ENGINEERS WERE ABLE TO IDENTIFY AGING AS THE ROOT CAUSE FOR THIS EVENT, AFTER NOTING THAT THE NEEDLE WAS RUSTED AND THE SEPTUM FRAYED. THE SEPTUM IS EXPECTED COMPLETELY CLOSE AFTER THE REMOVAL OF THE CANNULA, THIS SEAL PREVENTS THE LEAKAGE OF THE DEVICE. DURING OUR EVALUATION, THE SEPTUM OF THE RETURNED DEVICE WAS FOUND TO BE OPEN. FROM PREVIOUS INVESTIGATIONS WE KNOW, THAT AS THE SEPTUM AGES, THE SEPTUM WILL LOSE ELASTICITY. EXPERIMENTAL TESTING OF SEPTUMS IN HOT OF DRY ENVIRONMENTS DETERMINED THAT THE SEPTUM WILL AGE, LOSING ITS ELASTICITY AND ULTIMATELY FAILING TO SUCCESSFULLY CLOSE AFTER CANNULA REMOVAL. IN RESPONSE TO THIS EVENT WE HAVE NOTIFIED OUR CONTRACTED SHIPPING COMPANIES, AND RECOMMUNICATED BD'S EXPECTATIONS FOR THE IMPLEMENTATION OF ENVIRONMENTAL CONTROLS, DURING SHIPMENT AND STORAGE OF OUR DEVICES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLACK FOREIGN MATTER WAS FOUND ON THE INTIMA-II 20GAX1.16IN PRN SLM NPVC NEEDLE TIP BEFORE USE WHILE PREPARING THE PATIENT FOR PUNCTURE. THE HEPARIN CAP WAS ALSO FOUND TO BE DAMAGED. THIS OCCURRED ON 50 SEPARATE OCCASIONS, BUT THE DATES ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "WHEN THE NURSE PREPARED THE PATIENT FOR PUNCTURE, HE FOUND THAT THE TIP OF THE NEEDLE WAS BLACK AND HAD FOREIGN MATTERS. THE HEPARIN CAP(PRN) WAS DAMAGED. A BOX OF 50 HAD THE SAME PROBLEM."

    Additional Manufacturer Narrative · 1

    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 BLACK FOREIGN MATTER WAS FOUND ON THE INTIMA-II 20GAX1.16IN PRN SLM NPVC NEEDLE TIP BEFORE USE WHILE PREPARING THE PATIENT FOR PUNCTURE. THE HEPARIN CAP WAS ALSO FOUND TO BE DAMAGED. THIS OCCURRED ON 50 SEPARATE OCCASIONS, BUT THE DATES ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "WHEN THE NURSE PREPARED THE PATIENT FOR PUNCTURE, HE FOUND THAT THE TIP OF THE NEEDLE WAS BLACK AND HAD FOREIGN MATTERS. THE HEPARIN CAP(PRN) WAS DAMAGED. A BOX OF 50 HAD THE SAME PROBLEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868062 INTIMA-II 20GAX1.16IN PRN SLM NPVC INTRAVASCULAR CATHETER FPA BD (SUZHOU) 8141349

    Patients

    Seq Age Sex Outcome Treatment
    1 Other