MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 DAVOL SILICONE ROUND DOUBLE DRAIN, RELIAVAC 12.25" (30.5CM) HOLE PATTERN, 49" LO; BARD WOUND DRAIN

Catalog Number	0070730
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); No Code Available (3191)
Date of Event	09/12/2018
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 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 or Problem Description
It was reported that the drain tube was not opened.The day after placement of the drain the patient reported to the surgical clinic and it was noticed copious amounts of drainage from the peri-drain site.Upon removal of the drain, it was noted that approximately 3/4" of the drain was full of silicon.
Event or Problem Description
It was reported that the drain tube was not opened.The day after placement of the drain the patient reported to the surgical clinic and it was noticed copious amounts of drainage from the peri-drain site.Upon removal of the drain, it was noted that approximately 3/4" of the drain was full of silicon.Additional information was received on (b)(6)2018 that the drain was not replaced.The drain was not scheduled to be removed; however, it was removed the following day due to the patency issue.The drain had been originally placed for post operative wound drainage.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Corrections: concomitant medical products, initial reporter name and address:, device evaluated by mfr.
Event or Problem Description
It was reported that the drain tube was not opened.The day after placement of the drain the patient reported to the surgical clinic and it was noticed copious amounts of drainage from the peri-drain site.Upon removal of the drain, it was noted that approximately 3/4" of the drain was full of silicon.Additional information was received on (b)(6)2018 that the drain was not replaced.The drain was not scheduled to be removed; however, it was removed the following day due to the patency issue.The drain had been originally placed for post operative wound drainage.
Additional Manufacturer Narrative
The reported event was confirmed use related since the user did not cut the wound drain tubing as instructed in the ifu.Visual evaluation of the returned sample noted one opened (without original packaging), used silicone round drain with a suction bulb.The drain was filled with tissue and dried blood.A 0.8160" portion of the drain did not have a hollow center and was seemingly filled with silicone.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: "indications: wound drains are used to remove exudates from wound sites.Warning: when placing drain(s) care should be taken to ensure that the perforated portion of the wound drain lies completely within the confines of the wound.Read product insert provided with the closed wound evacuator for detailed instructions, warnings and precautions associated with the use of the evacuator device.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 for free motion during closure to minimize the 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.¿ surgical removal may be necessary if drain is difficult to remove or breaks.Drain placement a.Using a single silicone drain 1.Place perforated wound drain within critical fluid collection area of wound.2.Draw non-perforated section of wound drain through to the outside until drain indicator mark appears at the skin surface.Two sets of indicator marks aid placement of the drain.3.Trim non-perforated section of drain to desired length.4.Insert connecting tube of drain to drain port of evacuator.B.Using two silicone drains 1.Repeat steps 1-3 above.2.Attach proximal ends of silicone drains to the bard® y-connector (#0070790) and connect y-connector to evacuator drain port.C.Using a silicone double drain 1.Draw drain using trocar from outside into inside of wound then from inside to outside of wound on other side.2.Cut wound tube in the middle of perforated section.3.Remove trocar only by cutting the drain tubing one inch from end of trocar.4.Trim non-perforated section of drain to desired length.5.Attach drains to individual evacuators, or to y-connector 0070780 or 0070790.6.Insert other blue adapter into y-connector and attach drains to each blue adapter.7.Insert connecting tube into evacuator.Reuse precaution: this is a single use device.Do not re-sterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.".

• Brand Name: DAVOL SILICONE ROUND DOUBLE DRAIN, RELIAVAC 12.25" (30.5CM) HOLE PATTERN, 49" LO
• Common Device Name: BARD WOUND DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8071955
• Report Number: 1018233-2018-05364
• Device Sequence Number: 1693147
• Product Code: GBX
• UDI-Device Identifier: 00801741049552
• UDI-Public: (01)00801741049552
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/21/2019

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: 01/31/2023
• Device Catalogue Number: 0070730
• Device Lot Number: NGCN0316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 11/13/2018; 03/18/2019
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 12/01/2018; 03/21/2019
• 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: Other
• Patient Age: 60 YR