BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JINRO¿ PIGTAIL

    MDR report key: 2110064 · Received June 1, 2011

    Report

    Report Number
    3005099803-2011-01796
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFA
    PMA / PMN Number
    K944290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED 10 FR. FLEXIMA CATHETER REVEALED THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE METAL CANNULA WAS BENT AND THE PACKAGE (POUCH) WAS PERFORATED MAKING THE DEVICE NON STERILE. BASED ON THE PRODUCT ANALYSIS, THE PRODUCT PACKAGING DAMAGE AND STERILE BARRIER BREACH WAS LIKELY DUE TO SHIPPING/ TRANSIT HANDLING AND THE MOST PROBABLE ROOT CAUSE IS HANDLING DAMAGE. DURING MANUFACTURING, THE PACKAGED DEVICES ARE 100% INSPECTED FOR PACKAGE/ PRODUCT INTEGRITY. BOSTON SCIENTIFIC MANUFACTURING PROCESSES INCLUDE EXTENSIVE INSPECTIONS TO ENSURE THAT ALL FINISHED DEVICES MEET SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. AT THIS TIME WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    PLEASE NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES. REF: 3005099803-2011-01799. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT FLEXIMA CATHETER WAS USED IN AN UNKNOWN PROCEDURE (PATIENT IDENTIFIER, AGE, SEX, AND WEIGHT UNAVAILABLE). ACCORDING TO THE COMPLAINANT, A METAL WIRE INSIDE THE PACKAGE WAS NOTED TO BE BENT. THIS WIRE CAUSED A PERFORATION OF THE POUCH COMPROMISING STERILITY. THE PATIENT WAS REPORTED TO BE OKAY. SAME PROBLEM WITH 2 DEVICES.

    Description of Event or Problem · 1

    PLEASE NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES. REF: 3005099803-2011-01799. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT FLEXIMA CATHETER WAS USED IN AN UNKNOWN PROCEDURE (PATIENT IDENTIFIER, AGE, SEX, AND WEIGHT UNAVAILABLE). ACCORDING TO THE COMPLAINANT, A METAL WIRE INSIDE THE PACKAGE WAS NOTED TO BE BENT. THIS WIRE CAUSED A PERFORATION OF THE POUCH COMPROMISING STERILITY. THE PATIENT WAS REPORTED TO BE OKAY. SAME PROBLEM WITH 2 DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JINRO¿ PIGTAIL TUBE, DRAINAGE, SUPRAPUBIC FFA BOSTON SCIENTIFIC - SPENCER M0064202040 13801239

    Patients

    Seq Age Sex Outcome Treatment
    1