BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ROUND DRAIN

    MDR report key: 3037639 · Received April 2, 2013

    Report

    Report Number
    1018233-2013-01058
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 2, 2013
    Report Date
    March 4, 2013
    Manufacturer
    BARD MEDICAL DIVISION
    Product Code
    GBX
    PMA / PMN Number
    K782028
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE FINISHED PRODUCT MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. THE INSTRUCTIONS FOR USE STATES IN THE PRECAUTIONS: ADDITIONAL PERFORATIONS SHOULD NOT BE MADE IN THE DRAINS. AVOID SUTURING THROUGH DRAINS. DRAINS SHOULD LIE FLAT AND IN LINE WITH THE SKIN EXIT AREAS. PARTICULAR CARE SHOULD BE TAKEN TO AVOID ANY OBSTACLES TO THE DRAIN EXIT PATH. DRAINS SHOULD BE CHECKED FOR FREE MOTION DURING CLOSURE TO MINIMIZE THE POSSIBILITY OF BREAKAGE. DRAIN REMOVAL SHOULD BE DONE GENTLY BY HAND. THEY SHOULD NOT BE HANDLED WITH POINTED, TOOTHED OR SHARP INSTRUMENTS WHICH COULD CAUSE CUTS OR NICKS AND LEAD TO SUBSEQUENT STRUCTURAL FAILURE OF THE DRAIN. SURGICAL REMOVAL MAY BE NECESSARY IF DRAIN IS DIFFICULT TO REMOVE OR BREAKS." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE SURGEON WAS REMOVING THE DRAIN FROM THE PATIENT, THE DRAIN SNAPPED AT THE INSERTION SITE RESULTING IN THE PATIENT HAVING A SEPARATE PROCEDURE AT A LATER DATE TO REMOVE THE BROKEN PIECE. FURTHER INFORMATION RECEIVED INDICATED THAT THE DRAIN WAS PLACED FOR EXPLORATORY LAPAROTOMY FOR SPONTANEOUS PERFORATION OF THE SMALL BOWEL WITH ABSCESS AND ABDOMINAL CONTAMINATION, AND PARTIAL SMALL BOWEL OBSTRUCTION DISTAL TO THE PERFORATION. DURING THE PROCEDURE, A DRAIN WAS PLACED IN THE PELVIS PERCUTANEOUSLY THROUGH THE RIGHT LOWER QUADRANT, AND THIS WAS SUTURED TO THE SKIN SURFACE WITH A 2-0 PROLENE SUTURE. THE DOCTOR SUSPECTS THAT THE DRAIN WAS WEDGED IN BETWEEN RETENTION SUTURE AND ABDOMINAL TISSUE. THE DOCTOR REPORTED THAT THERE IS A GREAT DEAL OF THE PATIENT'S ANATOMY BEING PULLED TOGETHER BY RETENTION SUTURES DUE TO HIS MORBID OBESITY, WHICH PROBABLY CAUSED THE DRAIN TO BECOME DISLODGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133594 SILICONE ROUND DRAIN GBX BARD MEDICAL DIVISION NA NGWC0091

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention