BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿IV CATHETER

    MDR report key: 7173497 · Received January 8, 2018

    Report

    Report Number
    9610048-2017-00101
    Event Type
    Malfunction
    Date Received
    January 8, 2018
    Date of Event
    December 14, 2017
    Report Date
    December 18, 2017
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    PMA / PMN Number
    K950301
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: INVESTIGATION SUMMARY: A REVIEW OF THE PROVIDED PHOTO VERIFIED THE NEEDLE WAS BENT IN ONE OF THE SAMPLES. IT WAS NOT POSSIBLE TO VERIFY THE PRESENCE OF POWDER ON THE NEEDLE. NO RECORDS COULD BE FOUND THAT COULD LEAD TO EITHER OCCURRENCE WHEN ANALYZING THE DEVICE HISTORY RECORD AND QUALITY NOTIFICATIONS FOR THE CLAIMED LOT. BASED ON THE RESULTS OF THE INVESTIGATIONS, THE ROOT CAUSE OF THE DEFECTS RELATED TO THIS CLAIM WAS NOT DETERMINED BECAUSE OF THE PRESENCE OF OBJECTIVE EVIDENCE THAT COULD LEAD TO THESE OCCURRENCES. INVESTIGATION CONCLUSION: CONFIRMED: NEEDLE BENT - BD WAS ABLE TO CONFIRM/ REPRODUCE THE INCIDENT IN QUESTION. NOT CONFIRMED: FOREIGN MATTER - BD WAS UNABLE TO CONFIRM THE CUSTOMER COMPLAINT FOR THE CLAIMED DEFECT. INVESTIGATION COMMENTS: BENT NEEDLE: ALTHOUGH THE PHOTOS CONTAINING THE CLAIMED SAMPLES SHOWED THAT THE NEEDLE WAS BENT IN ONE OF THE SAMPLES, NO RECORDS WERE FOUND THAT COULD LEAD TO THIS OCCURRENCE. FOREIGN MATTER: DESPITE THE PHOTOS ATTACHED, IT WAS NOT POSSIBLE TO VERIFY THE PRESENCE OF FOREIGN MATTER (POWDER ON THE NEEDLE) AS REPORTED ONLY THROUGH THE PHOTOS. IN ADDITION, NO RECORDS WERE FOUND THAT COULD CLEARLY LEAD TO THE PRESENCE OF THIS TYPE OF FOREIGN MATTER REPORTED. SAMPLES/ PHOTOS: ACCORDING TO THE VISUAL ANALYSIS OF THE PHOTOS, IT WAS POSSIBLE TO VERIFY THAT THE NEEDLE WAS BENT. HOWEVER, IT WAS NOT POSSIBLE TO VERIFY THE PRESENCE OF FOREIGN MATTER ON THE CATHETER BODY ONLY THROUGH PHOTOS "POWDER ON THE NEEDLE" AS MENTIONED IN THAT COMPLAINT. DHR REVIEW: THE ANGIOCATH ASSEMBLED LOT: 7207669 USED IN THE FINAL PRODUCT LOT: 7241863 WERE ANALYZED FOR ¿BENT NEEDLE¿, ¿NEEDLE COILED/ BENT INSIDE NEEDLE COVER¿ AND ¿DAMAGED COMPONENT.¿ NONE OF THE RECORDS EVIDENCED COULD HAVE LED TO THIS DEFECT. THIS LOT WAS CHECKED AS TESTED FOR PRESENCE OF "FOREIGN / NO FOREIGN MATTER" AND NO RECORDS OF THIS DEFECT WERE FOUND. BASED ON A SEVERITY ASSESSMENT AND OCCURRENCE, IT WAS DETERMINED THAT NO CAPA IS REQUIRED AT THIS TIME. THE COMPLAINT WAS ADDED TO THE COMPLAINT DATABASE FOR TREND ANALYSIS, WHICH IS REGULARLY MONITORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE NEEDLE WAS FOUND BENT WITH ¿POWDER¿ IN THE NEEDLE OF A BD ANGIOCATH¿ IV CATHETER PRIOR TO USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16082 BD ANGIOCATH¿IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 7241863

    Patients

    Seq Age Sex Outcome Treatment
    1 Other