MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 RELIAVAC CLOSED WOUND SUCTION EVACUATOR; SILICONE EVACUATOR

Catalog Number 0070740

Device Problem Break (1069)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the drain port was broken prior to use.

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: "10.To avoid the possibility of drain damage or breakage, please follow these steps: a.Avoid suturing through drains.B.Drains should lie flat and in line with the skin exit areas.C.Particular care should be taken to avoid any obstacles to the drain exit path.D.Drains should be checked for free motion during closure to minimize the possibility of breakage.E.Drain removal should be done gently by hand.Drains should not be handled with pointed, toothed or sharp instruments as these could cause cuts or nicks and lead to subsequent structural failure of the drain.F.Surgical removal may be necessary if drain is difficult to remove or breaks.".

Event Description

It was reported that the drain port was broken prior to use.

• Brand Name: RELIAVAC CLOSED WOUND SUCTION EVACUATOR
• Type of Device: SILICONE EVACUATOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8203575
• MDR Text Key: 131743659
• Report Number: 1018233-2018-06236
• Device Sequence Number: 1
• Product Code: GCY
• UDI-Device Identifier: 00801741049569
• UDI-Public: (01)00801741049569
• 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: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0070740
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1