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

Catalog Number	0070440
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Sepsis (2067); Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that the wound drain broke when the surgeon was attempting removal.Part of the drain was retained in the abdomen.The patient's initial surgery was an exploratory laparotomy for abdominal abscess with signs and symptoms of sepsis.The procedure included lysis of adhesions and a left salpingo-oophorectomy.The drain was not sutured in place and removal attempt was three days post-op.The drain broke at the two drain eyes closest two the hub.A second surgery was required to remove the retained drain portion and it is reported the patient had no post-op complications.
Additional Manufacturer Narrative
The reported event could not be confirmed.No sample was returned for evaluation.A potential root cause for this failure mode could be "drain was manufactured incorrectly (dimensions or material out spec, curing time not appropriate, etc)." 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: "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 or Problem Description
It was reported that the wound drain broke when the surgeon was attempting removal.Part of the drain was retained in the abdomen.The patients initial surgery was an exploratory laparotomy for abdominal abscess with signs and symptoms of sepsis.The procedure included lysis of adhesions and a left salpingo-oopherectomy.The drain was not sutured in place and removal attempt was three days post-op.The drain broke at the two drain eyes closest two the hub.A second surgery was required to remove the retained drain portion and it is reported the patient had no post-op complications.

• Brand Name: HUBLESS SILICONE FLAT DRAIN, X-RAY OPAQUE STRIPE
• Common Device Name: WOUND DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8663788
• Report Number: 1018233-2019-02885
• Device Sequence Number: 13985782
• Product Code: GBX
• UDI-Device Identifier: 00801741090769
• UDI-Public: (01)00801741090769
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 0070440
• Device Lot Number: NGCY3062
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 06/25/2019
• 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: Required Intervention
• Patient Age: 22 YR