BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH PKGD: BERMAN 4 FR 5 0CM

    MDR report key: 2481121 · Received March 2, 2012

    Report

    Report Number
    2242445-2012-00039
    Event Type
    Malfunction
    Date Received
    March 2, 2012
    Date of Event
    February 20, 2012
    Report Date
    March 2, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQO
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    REFERENCE MDR NUMBER 2242445-2012-00038 FOR THE FIRST EVENT INVOLVING THE SAME PATIENT. IT WAS REPORTED THAT WHILE IN THE CATH LAB THE AI-07134 WAS PRETESTED PRIOR TO INSERTION AND THE BALLOON DID NOT FULLY INFLATE. AS A RESULT, ANOTHER AI-07134 WAS REQUESTED. THE THIRD BERMAN WAS PRE-TESTED SUCCESSFULLY AND ABLE TO BE USED FOR THIS PATIENT. THERE WAS NO REPORTED PATIENT DEATH OR INJURY. MEDICAL / SURGICAL INTERVENTION WAS NOT REQUIRED. THERE WAS NO DELAY OR INTERRUPTION REPORTED AND THE PATIENT DID NOT EXPERIENCE COMPLICATIONS. THE PATIENT OUTCOME IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH PKGD: BERMAN 4 FR 5 0CM BERMAN ANGIOGRAPHIC CATHETER PRODUCTS DQO ARROW INTL., INC. MF1038674

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN