MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 CHANNEL DRAIN,15FR.,ROUND,HUBLESS ONE-PIECE CHANNEL DRAIN; SILICONE CHANNEL DRAIN

Catalog Number	072228
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
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.
Event or Problem Description
It was reported that the silicone channel drain broke during removal leaving a portion inside of the patient.The patient required additional surgery to remove the fragment.
Additional Manufacturer Narrative
The reported event was confirmed; however, a root cause could not be determined.The inspector received one used silicone evacuator with a four channel drain.No packaging was included.It was noted that the drain was broken.The drain was broken at 20.5 cm.The outer diameter of the drain tubing was measured to be 0.1930 inches.Per specification, the outer diameter should be 0.197 +/-.013 inches.A potential root cause for this failure could be "drain was nicked with sharp object such as a trocar." the lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿drain placement · the surgeon should irrigate the wound with sterile fluid, then suction the irrigating fluid and gross debris from the operative site.· tubes should lie flat and in line with the anticipated skin exit.To facilitate later removal by manual traction, the tubing should not be curled, pinched, or sutured internally.· positioning of the drain in the body cavity, as well as the number of drains indicated, should be determined by the operating surgeon.· drain tubing should be placed within the wound by approximating the areas of critical fluid collection.· care must be taken to ensure that all drain perforations or channels lie completely within the wound or cavity to be drained.· taping or a triple loop suture (around and not through the tubing) will aid in preventing accidental drain displacement.· deep drainage is best accomplished by using one or more drains for each level of tissue.Each level should be evacuated by a separate vacuum source.· 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." patient code: 2564.
Event or Problem Description
It was reported that the silicone channel drain broke during removal leaving a portion inside of the patient.The patient required additional surgery to remove the fragment.The patient's initial surgery was a ventral hernia repair with mesh and drain placement.The drain removal was attempted on post-op day one.The drain was not sutured in place and excess force was not used during removal.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the silicone channel drain broke during removal leaving a portion inside of the patient.The patient required additional surgery to remove the fragment.The patient's initial surgery was a ventral hernia repair with mesh and drain placement.The drain removal was attempted on post-op day one.The drain was not sutured in place and excess force was not used during removal.

• Brand Name: CHANNEL DRAIN,15FR.,ROUND,HUBLESS ONE-PIECE CHANNEL DRAIN
• Common Device Name: SILICONE CHANNEL DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8624606
• Report Number: 1018233-2019-02630
• Device Sequence Number: 1654707
• Product Code: GBX
• UDI-Device Identifier: 00801741049880
• UDI-Public: (01)00801741049880
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2019

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: 072228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 05/24/2019; 06/26/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 06/06/2019; 07/17/2019
• 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: Required Intervention