BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER

    MDR report key: 7322616 · Received March 7, 2018

    Report

    Report Number
    9610048-2018-00017
    Event Type
    Malfunction
    Date Received
    March 7, 2018
    Date of Event
    February 22, 2018
    Report Date
    March 23, 2018
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    30382903811121
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBER CORRECTION: THE FOLLOWING FIELDS HAS BEEN CORRECTED: MEDICAL DEVICE LOT #: 7010867, MEDICAL DEVICE EXPIRATION DATE: 12/31/2021 AND DEVICE MANUFACTURE DATE: 01/23/2017.

    Additional Manufacturer Narrative · 0

    ALTHOUGH THERE ARE SAMPLES FOR ANALYSIS, THEY GOT STUCK IN CUSTOMS AND THE ONLY THING AVAILABLE FOR ANALYSIS ARE CUSTOMER PHOTOS. THE PHOTOS ARE NOT CONFIRMED FOR DISCOLORATION OF THE CATHETERS AS MENTIONED IN THIS COMPLAINT. SAMPLES/PHOTOS: ACCORDING TO THE VISUAL ANALYSIS OF THE RECEIVED PHOTOS, THE DISCOLORATION CANNOT BE VERIFIED, AS MENTIONED IN COMPLAINT. DHR REVIEW: THE FINAL ASSEMBLY BATCH: 6361823USED IN THE CLAIMED FINAL PRODUCT BATCH: 7010867 OF ANGIOCATH 24G X 0.75 IN WERE ANALYZED REGARDING ¿DAMAGED COMPONENT¿ AND WERE NOT EVIDENCED RECORDS THAT COULD LEAD TO CLAIMED DEFECT. QN/ NCMR REVIEW: THERE ARE NO QUALITY NOTIFICATION (QN) OR NONCONFORMITY REPORT OF "DAMAGED COMPONENT" OR ANYTHING THAT COULD LEAD TO THIS COMPLAINT. NOT CONFIRMED: BD WAS UNABLE TO CONFIRM THE INCIDENT IN QUESTION. BASED ON THE INVESTIGATIONS PERFORMED, IT WAS NOT POSSIBLE TO DETERMINE A ROOT CAUSE FOR THIS COMPLAINT.

    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 BEFORE USE OF THE BD ANGIOCATH¿ IV CATHETER CONNECTION THE CATHETER WAS DISCOLORED.¿ NO FURTHER INFORMATION. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164405 BD ANGIOCATH¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 7010867 30382903811121

    Patients

    Seq Age Sex Outcome Treatment
    1 Other