MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 HUBLESS SILICONE FLAT DRAIN, X-RAY OPAQUE STRIPE; FLAT SILICONE WOUND DRAIN

Catalog Number 0070440

Device Problems Break (1069); Entrapment of Device (1212); Physical Resistance (2578); Torn Material (3024)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/15/2018

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 after removing a bulb drain from a patient, it was noticed that the end of the drain appeared torn and not whole.An abdominal x-ray confirmed that a drain fragment remained in the patient.The patient required additional surgery to remove the fragment.There was slight resistance upon removal.The drain had been in place for 3 days.It was placed in the abdomen after a c section.After the internal broken section was retrieved it was matched up with the external broken fragment to confirm that there were no other pieces.The device was sent to pathology.The patient did not have any complications from the additional surgery.

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 states 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.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.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)".

Event Description

It was reported that after removing a bulb drain from a patient, it was noticed that the end of the drain appeared torn and not whole.An abdominal x-ray confirmed that a drain fragment remained in the patient.The patient required additional surgery to remove the fragment.There was slight resistance upon removal.The drain had been in place for 3 days.It was placed in the abdomen after a c section.After the internal broken section was retrieved it was matched up with the external broken fragment to confirm that there were no other pieces.The device was sent to pathology.The patient did not have any complications from the additional surgery.

• Brand Name: HUBLESS SILICONE FLAT DRAIN, X-RAY OPAQUE STRIPE
• Type of Device: FLAT SILICONE WOUND DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7542345
• MDR Text Key: 109218402
• Report Number: 1018233-2018-01892
• 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
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0070440
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 41 YR