MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SILICONE CHANNEL DRAIN WITH 3/16 IN. TROCAR, 15 FR., ROUND, 3/4 FLUTED

Catalog Number 072223

Device Problems Use of Device Problem (1670); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the channel drain was unable to drain during surgery.The channel drain was replaced.

Manufacturer Narrative

The reported event was confirmed as use related based on the sample evaluation and ifu.Visual evaluation noted a round silicone channel drain attached to tubing.The drain end was submerged in water and tubing connected to an in-house 3 spring evacuator.The evacuator was compressed and outlet port closed.The evacuator suctioned no water.The drain was disconnected and evacuator tested without it to ensure evacuator functioned with no issues.The drain was dissected to identify what appeared to be dried blood and/or human tissue clogging all 4 of the channels.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: "important: a.Check for fluid entering reliavac® evacuator.Lack of flow may indicate the following: i.All exudates have been removed.Ii.Wound drain is clogged and may require irrigation & aspiration (consult physician).Iii.Auxiliary wall suction pressure is above 210 mm hg.Iv.Deflated balloon: check all connections for air leak and drain perforations for exposure above the skin and follow step ¿11¿ above.If still deflated, replace the evacuator.B.When not using auxiliary suction during surgical wound closure, several activations of the reliavac® evacuator may be required to establish suction because of the following: i.Air entering partially closed wound.Ii.An operative air pocket.".

Event Description

It was reported that the channel drain was unable to drain during surgery.The channel drain was replaced.

• Brand Name: SILICONE CHANNEL DRAIN WITH 3/16 IN. TROCAR, 15 FR., ROUND, 3/4 FLUTED
• Type of Device: CHANNEL DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8217766
• MDR Text Key: 132225511
• Report Number: 1018233-2019-00108
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00801741049842
• UDI-Public: (01)00801741049842
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 072223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Date Manufacturer Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1