MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 HUBLESS SILICONE FLAT DRAIN, X-RAY OPAQUE STRIPE, 20CM LONG, FULL-LENGTH PERFORA; SILICOE DRAIN

Catalog Number 0070430

Device Problems Break (1069); Entrapment of Device (1212); Device Contamination with Chemical or Other Material (2944); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/05/2018

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device was not returned.

Event Description

It was reported that upon inspection of the channel drain after removal it appeared very short with a jagged edge.The nurse received orders to remove the drain from the physician.After removing the stitches, the nurse slowly removed the drain without encountering any resistance.A ct scan was done and confirmed that there was foreign matter approximately 3.7 cm deep.The patient was taken to surgery on (b)(+) 2018.The superior 2.5 cm of the wound was opened and the area as inspected, but the foreign material could not be found.One of the superior most fascial sutures was cut exposing the subfascial compartment.At that point the foreign piece of material was identified.There were not any sutures running through the foreign material, however the piece appeared to be severed off at the level of one of the fascial stitches.The foreign material was easily removed and the patient was discharged.

Manufacturer Narrative

The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "a.Check for fluid entering reliavac® evacuator.Lack of flow may indicate: - all exudate has been removed.- wound drain is clogged and may require irrigation and aspiration (consult physician).- auxiliary wall suction pressure is above 210mm hg.- deflated balloon: check all connections for air leak and wound tube perforations for exposure above the skin.If still deflated, replace 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: - air entering partially closed wound.- an operative air pocket.C.Insert safety pin into hole in collar to attach evacuator to patient's clothing or bed linen.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.To avoid the possibility of a hematoma due to wound evacuation, the instructions for use should be carefully followed.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 during closure for free motion to avoid 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.Warning: surgical removal may be necessary if drain is difficult to remove or breaks.Bard and reliavac are trademarks and/or registered trademarks of c.R.Bard, inc.© 2017 c.R.Bard, inc.All rights reserved.Bard manufacturer: c.R.Bard, inc.Covington, ga 30014 usa 1-800-526-4455 www.Bardmedical.Com reliavac® closed wound suction system with hubless silicone drains instructions for use indications for use: wound drains are used to remove exudates from wound sites contraindications: do not use for chest drainage.Warning: do not bypass/inactivate anti-reflux valve.Not made with natural rubber latex sterilized by ethylene oxide single use sterile unless package is opened or damaged.Do not use if package is opened or damaged.Do not resterilize caution units caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.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.".

Event Description

It was reported that upon inspection of the channel drain after removal it appeared very short with a jagged edge.The nurse received orders to remove the drain from the physician.After removing the stitches, the nurse slowly removed the drain without encountering any resistance.A ct scan was done and confirmed that there was foreign matter approximately 3.7 cm deep.The patient was taken to surgery on 07/06/2018.The superior 2.5 cm of the wound was opened and the area as inspected, but the foreign material could not be found.One of the superior most fascial sutures was cut exposing the subfascial compartment.At that point the foreign piece of material was identified.There were not any sutures running through the foreign material, however the piece appeared to be severed off at the level of one of the fascial stitches.The foreign material was easily removed and the patient was discharged.

• Brand Name: HUBLESS SILICONE FLAT DRAIN, X-RAY OPAQUE STRIPE, 20CM LONG, FULL-LENGTH PERFORA
• Type of Device: SILICOE DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7752232
• MDR Text Key: 116088013
• Report Number: 1018233-2018-03367
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00801741090752
• UDI-Public: (01)00801741090752
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 0070430
• Device Lot Number: NGCP1441
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR