BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE CHANNEL DRAIN WITH 3/16 IN. TROCAR, 10MM, FLAT, 3/4 FLUTED

    MDR report key: 6236587 · Received January 10, 2017

    Report

    Report Number
    1018233-2017-00052
    Event Type
    Injury
    Date Received
    January 10, 2017
    Report Date
    January 10, 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
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    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. THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "INDICATIONS: BARD® CHANNEL DRAINS, ROUND AND FLAT SILICONE, ARE INDICATED FOR USE WITH SELECTED BARD® EVACUATORS FOR CLOSED WOUND DRAINAGE FOLLOWING HEAD AND NECK, ORTHOPEDIC, ABDOMINAL, ENT, OB/GYN, PLASTIC, NEUROSURGERY, THORACIC AND CARDIOVASCULAR (CHANNEL DRAINS ONLY) PROCEDURES. TO AVOID THE POSSIBILITY OF DRAIN DAMAGE OR BREAKAGE: 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. DRAINS 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. DRAIN PLACEMENT: CARE MUST BE EXERCISED TO AVOID DAMAGE TO THE DRAIN (SEE WARNINGS). THE TUBING SHOULD BE REPEATEDLY CHECKED DURING CLOSURE FOR FREE MOTION TO AVOID BREAKAGE AND/OR FRAGMENT RETENTION WITHIN THE WOUND." (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. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON REMOVAL OF THE DEVICE, IT WAS NOTED THAT THE TIP OF THE DRAIN WAS ALLEGEDLY BROKEN. THE JP DRAIN WAS IMPLANTED ON (B)(6) 2016. THE COMPLAINANT STATED THAT ON (B)(6) 2016, THE NURSE ATTEMPTED TO REMOVE THE DRAIN FROM THE PATIENT'S LEFT GROIN AREA; HOWEVER, THE NEGATIVE PRESSURE WAS LET OFF OF THE JP DRAIN. AS A RESULT, THE SUTURES WERE CLIPPED. THE ATTEMPT TO PULL THE DRAIN OUT WAS UNSUCCESSFUL, AS THEY MET RESISTANCE. SUBSEQUENTLY, ANOTHER NURSE WAS CALLED IN TO CHECK THE JP DRAIN SITE. THE SECOND NURSE ALSO MET RESISTANCE, AND DID NOT FURTHER ATTEMPT TO REMOVE THE JP DRAIN. A NURSE PRACTITIONER WAS CALLED, AND WAS SUCCESSFUL IN REMOVING THE DRAIN; HOWEVER, UPON REMOVAL, THE TIP OF THE DRAIN WAS NOT INTACT. THE PHYSICIAN WAS NOTIFIED, AND SURGERY WAS PLANNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED IN REGARDS TO WHETHER OR NOT THE MISSING TIP HAS BEEN RETRIEVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON REMOVAL OF THE DEVICE, IT WAS NOTED THAT THE TIP OF THE DRAIN WAS ALLEGEDLY BROKEN. THE JP DRAIN WAS IMPLANTED ON (B)(6) 2016. THE COMPLAINANT STATED THAT ON (B)(6) 2016, THE NURSE ATTEMPTED TO REMOVE THE DRAIN FROM THE PATIENT'S LEFT GROIN AREA; HOWEVER, THE NEGATIVE PRESSURE WAS LET OFF OF THE JP DRAIN. AS A RESULT, THE SUTURES WERE CLIPPED. THE ATTEMPT TO PULL THE DRAIN OUT WAS UNSUCCESSFUL, AS THEY MET RESISTANCE. SUBSEQUENTLY, ANOTHER NURSE WAS CALLED IN TO CHECK THE JP DRAIN SITE. THE SECOND NURSE ALSO MET RESISTANCE, AND DID NOT FURTHER ATTEMPT TO REMOVE THE JP DRAIN. A NURSE PRACTITIONER WAS CALLED, AND WAS SUCCESSFUL IN REMOVING THE DRAIN; HOWEVER, UPON REMOVAL, THE TIP OF THE DRAIN WAS NOT INTACT. THE PHYSICIAN WAS NOTIFIED, AND SURGERY WAS PLANNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED IN REGARDS TO WHETHER OR NOT THE MISSING TIP HAS BEEN RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21601 SILICONE CHANNEL DRAIN WITH 3/16 IN. TROCAR, 10MM, FLAT, 3/4 FLUTED CHANNEL DRAIN GBX PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R