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 12/05/2018

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 drain port on the evacuator bulb was broken prior to use.

Event Description

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

Manufacturer Narrative

The reported event was confirmed as cause unknown.Visual inspection of the returned sample noted one 100cc silicone bulb evacuator with the inlet port on top of the evacuator broken off.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: ¿a.Use with single flat drain - 1.Place perforated wound drain within critical fluid collection area of wound.2.Draw drain tube through skin/stab wound incision until flat portion of drain is seated appropriately.3.Trim drain tube to desired length and attach to blue adapter.Connect other end of blue adapter to y-connector.4.Insert connecting tube in reliavac® port a, up to indicator ring.B.Use with two flat drains - 1.Place perforated portion of wound drains within critical fluid collection areas of wound.2.Draw drain tubes through skin/stab wound incision until flat portion of the drains are seated appropriately.3.Trim drain tubes to desired length.4.Cut off plug from closed arm of y-connector and attach blue adapters.5.Attach drains to blue adapters.6.Insert connecting tube in reliavac® port a, up to indicator ring.Caution: punctures or additional perforations should not be made in the silicone wound drain.C.Attaching to auxiliary suction - 1.Insert suction adapter into port b.2.During auxiliary suction, balloon will inflate and exudate will flow over balloon surface from port a to port b.3.To discontinue auxiliary suction, remove suction adapter and close port b.Caution: do not use with wall suction in excess of 210mm hg.D.To establish suction - 1.Open port b.2.Pump bulb until balloon fills container.3.Close port b.Note: hissing sound is normal and stops when maximum suction pressure is reached.Possible reflux of fluid to the patient is reduced during reliavac® evacuator reactivation by a built-in anti-reflux valve in port a.E.To empty container - 1.Open port b.2.Invert unit.3.Pump bulb to empty quickly.F.To re-establish suction - 1.Repeat step "d" above.G.To read fluid volume - 1.Open port b.2.Allow balloon to deflate.3.Read and record volume.4.To reactivate, repeat step "d" above.".

• 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: 8201411
• MDR Text Key: 131590457
• Report Number: 1018233-2018-06222
• 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: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Date Manufacturer Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1