MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 DAVOL SILICONE ROUND SINGLE DRAIN; WOUND DRAIN

Catalog Number 0070320

Device Problem Break (1069)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

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 were found adequate and state the following: ¿when placing drain(s) care should be taken to ensure that the perforated portion of the wound drain lies completely within the confines of the wound.Read product insert provided with the closed wound evacuator for detailed instructions, warnings and precautions associated with the use of the evacuator device.To avoid the possibility of drain damage or breakage: 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 for free motion during closure to minimize the 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.Drain placement.Using a single silicone drain: place perforated wound drain within critical fluid collection area of wound.Draw non-perforated section of wound drain through to the outside until drain indicator mark appears at the skin surface.Two sets of indicator marks aid placement of the drain.Trim non-perforated section of drain to desired length.Insert connecting tube of drain to drain port of evacuator.Using two silicone drains: repeat steps 1-3 above.Attach proximal ends of silicone drains to the bard® y-connector (#0070790) and connect y-connector to evacuator drain port.Using a silicone double drain: draw drain using trocar from outside into inside of wound then from inside to outside of wound on other side.Cut wound tube in the middle of perforated section.Remove trocar only by cutting the drain tubing one inch from end of trocar.Trim non-perforated section of drain to desired length.Attach drains to individual evacuators, or to y-connector 0070780 or 0070790.Insert other blue adapter into y-connector and attach drains to each blue adapter.Insert connecting tube into evacuator." (b)(4).

Event Description

It was reported that the wound drain broke half-way through the removal process with part of it still in the patient after approximately 2-months of use.Patient was taken to surgery to have the remainder of the drain removed.Allegedly, the doctor had to "tease away" tissue in-growth from multiple locations with in the drain.

• Brand Name: DAVOL SILICONE ROUND SINGLE DRAIN
• Type of Device: WOUND DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 8776770
• MDR Text Key: 150585334
• Report Number: 1018233-2019-03830
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00801741049477
• UDI-Public: (01)00801741049477
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0070320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2019
• 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
• Patient Outcome(s): Required Intervention