BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSORB 0 VL 5X18 BTP-1 DT

    MDR report key: 6236227 · Received January 10, 2017

    Report

    Report Number
    9612501-2017-00061
    Event Type
    Injury
    Date Received
    January 10, 2017
    Date of Event
    December 9, 2016
    Report Date
    December 12, 2016
    Manufacturer
    COVIDIEN
    Product Code
    GAM
    PMA / PMN Number
    K963253
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. VISUAL INSPECTION OF THE RETAINER NOTED THAT FOUR WITNESS MARKS WERE PRESENT, WHILE THE CORRECT NUMBER OF UNITS FOR THIS PRODUCT IS FIVE; THIS SERVES AS AN INDICATION THAT THE INCORRECT NUMBER OF UNITS WAS PLACED IN THE PACKAGING AT THE TIME OF MANUFACTURE. THE ROOT CAUSE OF THE OBSERVED CONDITION WAS DETERMINED TO BE A RESULT OF AN ASSEMBLY ERROR. THIS ISSUE HAS BEEN BROUGHT TO THE ATTENTION OF THE APPROPRIATE MANUFACTURING PERSONNEL AND A PROCESS ENHANCEMENT HAS BEEN IMPLEMENTED TO PREVENT THIS CONDITION FROM RECURRING. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER STATES: AFTER SURGERY, THEY COUNTED THE NUMBER OF THE NEEDLES AND NOTED THE NUMBER DID NOT CORRESPOND. THEY LOOKED FOR THE NEEDLE, BUT WERE NOT ABLE TO FIND IT OUT. SURGEON DECIDED TO CLOSE THE ABDOMEN AS HE/SHE THOUGHT THE NEEDLE HAD NOT BEEN CONTAINED IN THE PACKET FROM THE BEGINNING. HOWEVER, POSTOPERATIVELY THE PATIENT UNDERWENT A CT SCAN TO BE SAFE. THE EVENT OCCURRED IN USE FOR PATIENT. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MIN. THE STATUS OF THE PATIENT: NO PROBLEM. THERE WAS NO TISSUE DAMAGE. THE INCISION SITE WAS NOT EXTENDED. NOTHING FELL INTO THE PATIENT'S CAVITY. NO BLEEDING OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21333 POLYSORB 0 VL 5X18 BTP-1 DT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GAM COVIDIEN CLT250MG D6B2566X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention