BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUBLESS SILICONE FLAT DRAIN

    MDR report key: 6447395 · Received March 30, 2017

    Report

    Report Number
    1018233-2017-01432
    Event Type
    Injury
    Date Received
    March 30, 2017
    Report Date
    August 16, 2017
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590
    Product Code
    GBX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PHYSICAL SAMPLE WAS RECEIVED FOR EVALUATION; HOWEVER, A PHOTO WAS RECEIVED SHOWING A USED PARTIAL SAMPLE OF A FLAT DRAIN. DURING THE VISUAL EVALUATION OF THE PHOTO, BREAKAGE WAS OBSERVED BUT IT WAS NOT POSSIBLE TO DEFINE IF PART OF ONE EYE WAS BROKEN. ACCORDING TO PRODUCT CATALOG NO. 0070440 THE FLAT DRAIN SA7601277 - 10MM WITH 72 HOLES DRAIN. PER PICTURE RECEIVED 27 HOLES ARE OBSERVED IN THE BROKEN PIECE (WHITE). THE REPORTED EVENT WAS CONFIRMED WITH AN UNKNOWN CAUSE. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "¿ 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 DURING CLOSURE FOR FREE MOTION TO AVOID 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). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. RECEIVED PHOTO SAMPLE ONLY.

    Additional Manufacturer Narrative · 1

    RECEIVED 1 USED WOUND DRAIN ONLY, THE CLEAR TUBE AND WHITE DRAIN WERE CUT. THE REPORTED EVENT WAS CONFIRMED WITH AN UNKNOWN CAUSE. DURING THE VISUAL EVALUATION OF THE RECEIVED SAMPLE, IT WAS NOTED THAT THE WOUND FLAT DRAIN WAS BROKEN INTO TWO PIECES. THE FLAT DRAIN WAS BROKEN AT THE EYES SECTION. ONE PIECE (SECTION OF THE TUBE AND THE FLAT DRAIN) MEASURED 4 3/8¿ (4.375¿) AND THE OTHER (SECTION OF THE FLAT DRAIN) MEASURED ½¿ (0.5¿). IN BOTH PIECES, IT WAS OBSERVED THAT THERE WERE JAGGED EDGES. THE DIMENSIONS OF THE CLEAR TUBE WERE MEASURED AND THE RESULTS WERE AS FOLLOWS: DIMENSION A= 0.169¿ (SPECIFICATION (0.176¿ ±0.010¿)), DIMENSION B = 0.431¿ (SPECIFICATION (0.434¿ ±0.010¿)), DIMENSION C = 0.035¿ (SPECIFICATION (0.035¿ ±0.006¿)), DIMENSION D = 0.033¿ (SPECIFICATION (0.032¿ ±0.006¿)). THE DIMENSIONS OF THE FLAT DRAIN WERE FOUND WITHIN SPECIFICATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "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 DURING CLOSURE FOR FREE MOTION TO AVOID 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).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WOUND DRAIN BROKE INTO TWO PIECES, AND ONE PIECE REMAINED INSIDE OF THE PATIENT. THE PATIENT HAD TO ALLEGEDLY RETURN TO SURGERY TO REMOVE THE REMAINING PIECE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WOUND DRAIN BROKE INTO TWO PIECES, AND ONE PIECE REMAINED INSIDE OF THE PATIENT. THE PATIENT HAD TO ALLEGEDLY RETURN TO SURGERY TO REMOVE THE REMAINING PIECE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WOUND DRAIN BROKE INTO TWO PIECES, AND ONE PIECE REMAINED INSIDE OF THE PATIENT. THE PATIENT HAD TO ALLEGEDLY RETURN TO SURGERY TO REMOVE THE REMAINING PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229161 HUBLESS SILICONE FLAT DRAIN WOUND DRAIN GBX PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R