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

Catalog Number 0070440

Device Problems Break (1069); Restricted Flow rate (1248); Mechanical Problem (1384); Suction Problem (2170)

Patient Problems Injury (2348); Fasciitis (2375); Foreign Body In Patient (2687)

Event Date 04/11/2017

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 the wound drain suffered a ¿pure mechanical failure¿.The patient underwent c5-t1 laminectomy and fusion surgery with the placement of two drains during the procedure on (b)(6) 2017 at (b)(6) hospital in (b)(6).One of the drains allegedly failed and the patient required additional surgery to remove the alleged failed drain.The procedure description noted there was no suture incarcerating the drain.During the surgery to remove the drain, the surgeon noted fascial layer dehiscence which required opening of the whole incision, irrigation, and debridement deep to the fascia, down to the spine and hardware.A new drain was placed and antibiotic powder placed in the wound prior to re-closing the wound.

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 state the following: "important 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.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.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.Use with single flat drain - place perforated wound drain within critical fluid collection area of wound.Draw drain tube through skin/stab wound incision until flat portion of drain is seated appropriately.Trim drain tube to desired length and attach to blue adapter.Connect other end of blue adapter to y-connector.Insert connecting tube in reliavac® port a, up to indicator ring.Use with two flat drains - place perforated portion of wound drains within critical fluid collection areas of wound.Draw drain tubes through skin/stab wound incision until flat portion of the drains are seated appropriately.Trim drain tubes to desired length.Cut off plug from closed arm of y-connector and attach blue adapters.Attach drains to blue adapters.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.Attaching to auxiliary suction - insert suction adapter into port b.During auxiliary suction, balloon will inflate and exudate will flow over balloon surface from port a to port b.To discontinue auxiliary suction, remove suction adapter and close port b.Caution: do not use with wall suction in excess of 210mm hg.To establish suction - open port b.Pump bulb until balloon fills container.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.To empty container - open port b.Invert unit.Pump bulb to empty quickly.To re-establish suction - repeat step "d" above.To read fluid volume - open port b.Allow balloon to deflate.Read and record volume.To reactivate, repeat step "d" above.(continued.) closed wound suction system components connecting tube y-connector collar flat drain drain eyes drain tube suction adapter collar evacuator container balloon within container blue adapter port a (inlet port) indicator ring squeeze bulb (to pump up balloon) drain port b (outlet port)." the device was not returned.

Event Description

It was reported that the wound drain suffered a ¿pure mechanical failure¿.The patient underwent c5-t1 laminectomy and fusion surgery with the placement of two drains during the procedure on (b)(6) 2017 at parkview orthopedic hospital in fort wayne, indiana.One of the drains allegedly failed and the patient required additional surgery to remove the alleged failed drain.The procedure description noted there was no suture incarcerating the drain.During the surgery to remove the drain, the surgeon noted fascial layer dehiscence, which required opening of the whole incision, irrigation, and debridement deep to the fascia, down to the spine and hardware.A new drain was placed and antibiotic powder placed in the wound prior to re-closing the wound.

Manufacturer Narrative

The reported event was confirmed.Visual evaluation of the returned sample noted the drainage tubing end of a used wound drain with a diagonal break.The other half was not present in the photo sample.Damage to the wound drain shaft is considered out of specification.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and 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.".

Event Description

It was reported that the wound drain suffered a ¿pure mechanical failure¿.The patient underwent posterior cervical fusion c5-6 and c6-7 fusion and c5, c6, and c7 laminectomies with the placement of two drains during the procedure on(b)(6)2017 , and was discharged on(b)(6)2017 at parkview orthopedic hospital in fort wayne, indiana.One of the drains allegedly failed and the patient required additional surgery to remove the failed drain.The procedure description noted there was no suture incarcerating the drain.During the surgery to remove the drain, the surgeon noted fascial layer dehiscence which required opening of the whole incision, irrigation, and debridement deep to the fascia, down to the spine and hardware.A new drain was placed and antibiotic powder placed in the wound prior to re-closing the wound.Additional information was received that it was on (b)(6)2017 , when the patient went in for a follow-up, that the surgeon advised the patient that the x-rays revealed an "artifact" in her neck.(b)(6)2017 was the day the additional surgery was done to remove the piece from the patient's neck and repair of fascial dehiscence.Operating notes were received on (b)(6)2017 , and noted that pain medication was given at discharge.Additional information was later received from the operating report on (b)(6)2019, that upon removal of the drain, the sutures were cut and the drains turned to release the sutures.When the drain was twisted on the right side, it began having an increased output.The output was recorded as 40 cc.The drain was left in place on suction and the output was monitored for 4 hours.The right drain was re-secured with steri strips.The patient had a plastic surgeon consult on (b)(6)2017 for evaluation of tissue quality due to increased risk of dehiscence and/or other healing problems.There was a review of the drain on (b)(6)2017 at 1749, and there was new drainage from the incision, and had a shadow of red in color.The drainage had stopped by midnight, per the nurse¿s documentation.

• Brand Name: HUBLESS SILICONE FLAT DRAIN, X-RAY OPAQUE STRIPE, 20CM LONG, FULL-LENGTH PERFORA
• Type of Device: HUBLESS FLAT SILICONE DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7452414
• MDR Text Key: 106247056
• Report Number: 1018233-2018-01298
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00801741090769
• UDI-Public: (01)00801741090769
• 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,Followup
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 0070440
• Device Lot Number: NGBX1413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Date Manufacturer Received: 03/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 86