BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 7304602 · Received February 28, 2018

    Report

    Report Number
    3006948883-2018-00023
    Event Type
    Malfunction
    Date Received
    February 28, 2018
    Date of Event
    February 5, 2018
    Report Date
    March 26, 2018
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    K143610
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER IN SUPPORT OF THE COMPLAINT. THE RETURNED SAMPLES WERE EVALUATED AND A LEAKAGE TEST WAS CONDUCTED. LEAKAGE WAS OBSERVED ON THE TOP OF THE PP LUER CONNECTOR. CHECKED THE LEAKAGE POSITION, AND FOUND THE EXTENSION TUBING HAS BEEN DAMAGED. DISSECT THE LUER CONNECTOR, THERE WAS WOND ON THE EXTENSION TUBING, AND THE WOUND DIRECTION IS FROM INSIDE OUT, THE DAMAGE SHAPE IS V, AND IT IS CONSISTENT WITH THE NEEDLE TIP, SO THE EXTENSION TUBING MAY BE PIERCED BY THE NEEDLE. THE COMPLAINT INFORMATION FEEDBACK, NURSE FOUND LEAKAGE BETWEEN Y CONNECTION SITE WITH E-TUBING DURING INFUSION ON FEBRUARY 5, THE COMPLAINT INFORMATION SHOWS, NO ABNORMALITY WAS OBSERVED ON THE PUNCTURE OF THE FIRST DAY, NO ABNORMALITY WAS OBSERVED ON THE PREVIOUS 3 DAYS OF INDWELLING TIME. NURSE FOUND LEAKAGE DURING INFUSION ON FEBRUARY 5. THE DAMAGED POSITION AT THE TOP OF THE PP LUER CONNECTOR, THE PINCH CLAMP CANNOT CONTACT THE DAMAGE POSITION. DHR REVIEW: MFG DATE OF THIS LOT #7365047 IS NOVEMBER 2018. QTY IS 136K IN AUTO LINE 3 #. MFG DATE OF THIS LOT #7234113 IS OCTOBER 2018. QTY IS 136K IN AUTO LINE 2 #. NO ABNORMAL RECORDS FOR THE BATCH RECORD. INVESTIGATION CONCLUSION: NO ABNORMALITY WAS OBSERVED ON THE PUNCTURE OF THE FIRST DAY, NO ABNORMALITY WAS OBSERVED ON THE PREVIOUS 3 DAYS OF INDWELLING TIME, THE DAMAGE SHAPE IS V, IT IS CONSISTENT WITH THE NEEDLE TIP, SO THE EXTENSION TUBING MAY BE PIERCED BY THE NEEDLE.

    Additional Manufacturer Narrative · 1

    TWO POTENTIAL LOT NUMBERS WERE PROVIDED FOR THIS INCIDENT. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS:  MEDICAL DEVICE LOT #: 7265047, EXPIRATION DATE: 2020-11-12, MANUFACTURE DATE: 2017-09-22. MEDICAL DEVICE LOT #:7234113, EXPIRATION DATE: 2020-10-10, MANUFACTURE DATE: 2017-08-22. 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 NURSE FOUND LEAKAGE ON A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM BETWEEN THE Y CONNECTION SITE WITH E-TUBING DURING INFUSION. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145182 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other