MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 SILICONE CHANNEL DRAIN WITH 3/16 IN. TROCAR, 19 FR., ROUND, 3/4 FLUTED

Catalog Number	072225
Health Effect - Clinical Codes	Unspecified Infection (1930); Bowel Perforation (2668)
Date of Event	06/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that in (b)(6) 2017, a patient had an inguinal hernia repair.In (b)(6) 2017, the bowel was impacted and an ileus was formed.A channel drain was placed to help drain the wounds around the ileum.No abnormalities such as, device damage or occlusion were observed after placement.However, on (b)(6) 2017, the ninth day of placement, the outflow of intestinal fluid through the channel drain was found.There was an incisional infection caused by a bowel perforation.The facility stated that the channel drain may have adhered to the post-surgical bowel relating to this event.An additional surgery was done where a colostomy was placed.It was later reported that the colostomy is temporary and will be removed as soon as the wound recovers.
Additional 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: "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.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.Complications complications which may result from the use of this suction drainage system include the risks associated with methods utilized in the surgical procedure, as well as the patients degree of intolerance to any foreign object in the body.Do not use if package is damaged." (b)(4).
Event or Problem Description
It was reported that in (b)(6) 2017, a patient had an inguinal hernia repair.In (b)(6) 2017, the bowel was impacted and an ileus was formed.A channel drain was placed to help drain the wounds around the ileum.No abnormalities such as, device damage or occlusion were observed after placement.However, on (b)(6) 2017, the ninth day of placement, the outflow of intestinal fluid through the channel drain was found.There was an incisional infection caused by a bowel perforation.The facility stated that the channel drain may have adhered to the post-surgical bowel relating to this event.An additional surgery was done where a colostomy was placed.It was later reported that the colostomy is temporary and will be removed as soon as the wound recovers.

• Brand Name: SILICONE CHANNEL DRAIN WITH 3/16 IN. TROCAR, 19 FR., ROUND, 3/4 FLUTED
• Common Device Name: CHANNEL DRAIN
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora GA 85621 ; MX 85621
• MDR Report Key: 6822069
• Report Number: 1018233-2017-04454
• Device Sequence Number: 13467825
• Product Code: GBX
• UDI-Device Identifier: 00801741049859
• UDI-Public: (01)00801741049859
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 072225
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2017
• Supplement Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 08/25/2017
• Supplement Report FDA Received Date: 09/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention