MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 RELIAVAC CLOSED WOUND SUCTION SYSTEM WITH HUBLESS SILICONE FLAT DRAIN, X-RAY OPA

Model Number	0070370
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.
Event or Problem Description
It was reported that there was a breakage in the middle of the flat drain tube.
Additional Manufacturer Narrative
The reported event was unconfirmed because the reported failure could not be reproduced.Visual evaluation of the returned sample noted one opened (without original packaging), used silicone channel drain.Visual inspection of the sample noted no obvious visible defects, such as damage or breakage on the drain.The length of the white channel drain was 8.25" which was within specification (8.08"±0.30").As there are no pieces that seem to be missing, this meets the specification "no damaged or missing components." no root cause could be found because the reported event was unconfirmed.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.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.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." h11: section a through f - 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.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that there was a breakage in the middle of the flat drain tube.

• Brand Name: RELIAVAC CLOSED WOUND SUCTION SYSTEM WITH HUBLESS SILICONE FLAT DRAIN, X-RAY OPA
• Common Device Name: SILICONE FLAT DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11056133
• Report Number: 1018233-2020-21905
• Device Sequence Number: 3000283
• Product Code: GBX
• UDI-Device Identifier: 00801741090745
• UDI-Public: (01)00801741090745
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: 0070370
• Device Catalogue Number: 0070370
• Device Lot Number: NGEQ4574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other