BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO SUTURE DEK BL MF 48"

    MDR report key: 2142060 · Received May 24, 2011

    Report

    Report Number
    3004365956-2011-00209
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    March 18, 2011
    Report Date
    May 12, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    MFJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: DEVICE HISTORY RECORD REVIEW, HISTORY REVIEW RANGE FROM: 05/15/2010 TO 05/15/2011. RESULTS: DEVICE HISTORY RECORD REVIEW SHOWED NO ISSUES OR DISCREPANCIES WHICH COULD POTENTIALLY RELATE TO THE COMPLAINT REPORTED. TEST CARDS WERE REVIEWED FROM MANUFACTURING AND QUALITY WHICH FOUND THAT ON THE ATTACHMENT STRENGTH TEST AND INDIVIDUAL MINIMUM VALUE ON MANUFACTURING TEST CARD WAS 6.8 LB. AND ON THE QUALITY TEST CARD, IT WAS 7.0 LB. IN COMPARISON WITH THE REQUIREMENTS ON THE INDIVIDUAL MINIMUM VALUE OF 5.8 LB. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN. NO EVALUATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: DURING THE ANTERIOR PORTION OF THE PROCEDURE, THE NEEDLE OF THE CAPIO SUTURE BROKE OFF THE SUTURE AND BECAME LODGED WITHIN THE PATIENT'S TISSUE OF THE LEFT SIDE. THE NEEDLE WAS NOT RETRIEVED FROM THE PATIENT AS THE DOCTOR FELT IT WOULD NOT CAUSE ANY HARM TO THE PATIENT. IT IS REPORTED THAT THERE IS NO COMPLICATIONS AND THAT THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIO SUTURE DEK BL MF 48" CAPIO SUTURE MFJ TELEFLEX MEDICAL NA 02E0802716

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR