MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 SILICONE CHANNEL DRAIN WITH 3/16 IN. TROCAR, 15 FR., ROUND, FULL FLUTED

Catalog Number 072189

Device Problem Collapse (1099)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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 states the following precautions to avoid the possibility of occlusion in the drain: "warnings: an effective closed suction drain system requires maintenance of the system to preserve patency.The drain must not be allowed to occlude nor the reservoir to completely fill; and reservoir suction must be maintained in order for the system to function properly.Verify that the system is functioning properly.If the system is not maintained properly, surgical complications, including hematomas, may result.In the event of occlusion of the drain, all wound drainage via the drain ceases.Careful attention to the drain will minimize the possibility of this problem.If occlusion does occur, the drain can be aspirated by connecting suction to the reservoir outlet or temporarily disconnecting the drain from the reservoir and applying suction directly to the drain.If an air-tight seal between the drain and the skin where the drain emerges is not achieved, the air leak must be rectified or the system must be converted to open drainage.An airtight seal between all system components (drain, adaptor and reservoir) is necessary for proper system function.Leaving the soft silicone elastomer drain implanted for any period of time so as to cause tissue ingrowth around the drain can interfere with easy removal and may affect the performance of the drain.The surgeon should monitor the patient¿s rate of wound healing.Evacuators should be used in cardio-thoracic surgery only after the lung is fully expanded and all air leaks have sealed.Drain perforations or channels must lie within the wound or cavity to be drained, otherwise inadequate drainage may result." (b)(4).Corrected data: 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.

Event Description

It was reported that the drain collapsed post-surgery.Additional surgery was not needed; however, the device was replaced.

• Brand Name: SILICONE CHANNEL DRAIN WITH 3/16 IN. TROCAR, 15 FR., ROUND, FULL FLUTED
• Type of Device: SILICONE CHANNEL DRAIN
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6396581
• MDR Text Key: 69962085
• Report Number: 1018233-2017-01012
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 072189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1