BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INTIMA II¿ IV CATHETER

    MDR report key: 7274555 · Received February 15, 2018

    Report

    Report Number
    3006948883-2018-00010
    Event Type
    Injury
    Date Received
    February 15, 2018
    Date of Event
    January 21, 2018
    Report Date
    February 22, 2018
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    K100775
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: SAMPLES WERE RETURNED AND EVALUATED AS WELL AS RETENTION SAMPLES WERE INSPECTED. REPORTED DEFECT WAS OBSERVED, THE NEEDLE¿S TOP AND BOTTOM WAS BENT. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMERS INDICATED FAILURE MODE. INVESTIGATION CONCLUSION: THE HOSPITAL COMPLAINED PRODUCT CATALOG #401622, BATCH NUMBER 7233036, SPINAL NEEDLE REMOVAL WAS DIFFICULT. REVIEWED THE BATH RECORD, NO ABNORMALITY WAS FOUND IN THE PACKAGING PROCESS AND INSPECTION PROCESS. CHECKED THE RETENTION SAMPLES, THE NEEDLE WAS OKAY. THE HOSPITAL RETURNED 1 PCS SAMPLE WITHOUT UNIT PACKAGE, CHECKED THE RETURNED SAMPLES, THE CANNULA WAS OKAY AND NOT BENT, BUT THE REMOVAL WAS DIFFICULT, AFTER THE REMOVAL, WE FOUND THE NEEDLE TO BE BENT AT THE TOP AND END. ROOT CAUSE DESCRIPTION: MATERIAL DEFECT, NO CAPA IMITATED. DHR- NO RELATED INVESTIGATIONS ON SAME LOT NUMBER. MANUFACTURING INVESTIGATION: THE PRODUCTS¿ CATALOG #401622, LOT # 723336 WERE PACKAGED ON SEPTEMBER 2017, THE PACKAGED QUANTITY WAS 1.4 K. AFTER REVIEWING THE BATCH RECORD, NO ABNORMITY WAS FOUND IN THE PACKAGING PROCESS. INSPECTION INVESTIGATION: REVIEWED BATCH RECORD, THE INSPECTION PROCESS AND OUTGOING PROCESS BOTH MET THE REQUIREMENTS, NO ABNORMALITY WAS FOUND.

    Additional Manufacturer Narrative · 1

    INITIAL MDR WAS SUBMITTED WITH "A LITTLE BLOOD LEAKAGE AND DISINFECTED TREATMENT IMMEDIATELY¿ WAS NEEDED. ADDITIONAL INFORMATION PROVIDED STATES ¿DISINFECTED TREATMENT¿ MEANS' THE NURSE WASH HER FINGER WHICH WAS STUCK BY THE NEEDLE WITHOUT NEEDLE COVER, THEN USE AN ALCOHOL WIPE TO CLEAN PUNCTURE:" ACCORDING TO THE NEW INFORMATION PROVIDED THIS REPORT IS NON- REPORTABLE AS INTERVENTION WAS FIRST AID, NOT MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE, A NURSE OPENED THE UNIT PACKAGE AND FOUND A BD INTIMA-II CATHETER BENT AND WITHOUT THE NEEDLE COVER IN PLACE. THIS RESULTED IN A CLEAN NEEDLE STICK.¿ A LITTLE BLOOD LEAKAGE AND DISINFECTED TREATMENT IMMEDIATELY¿ WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116905 BD INTIMA II¿ IV CATHETER PERIPHERAL INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 7265044

    Patients

    Seq Age Sex Outcome Treatment
    1 Other