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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 DAVOL SILICONE ROUND SINGLE DRAIN; WOUND DRAIN
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C.R. BARD, INC. (COVINGTON) -1018233 DAVOL SILICONE ROUND SINGLE DRAIN; WOUND DRAIN Back to Search Results
Catalog Number 0070230
Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Patient Problems Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
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 Description
It was reported that upon removal of the wound drain, 27 days after placement, the physician met resistance when pulling on the wound drain.The physician aborted the removal indicating that if the drain was pulled on any harder, it would have broken in half leaving a piece in the patient.The patient was later taken to the operating room, requiring general anesthetic and laparoscopy to remove the drain surgically.
 
Manufacturer Narrative
This report is being submitted past the regulatory timeframe.Please see attached letter for additional information.The device was not returned for evaluation.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.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." patient code: (b)(4).
 
Event Description
It was reported that upon removal of the wound drain, 27 days after placement, the physician met resistance when pulling on the wound drain.The physician aborted the removal indicating that if the drain was pulled on any harder, it would have broken in half leaving a piece in the patient.The patient was later taken to the operating room, requiring general anesthetic and laparoscopy to remove the drain surgically.
 
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Brand Name
DAVOL SILICONE ROUND SINGLE DRAIN
Type of Device
WOUND DRAIN
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key8524423
MDR Text Key142324566
Report Number1018233-2019-02005
Device Sequence Number1
Product Code GBX
UDI-Device Identifier00801741049453
UDI-Public(01)00801741049453(10)
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 05/31/2019
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
Device Operator Health Professional
Device Expiration Date09/30/2023
Device Catalogue Number0070230
Device Lot NumberNGCW0361
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/25/2019
Initial Date FDA Received04/17/2019
Supplement Dates Manufacturer Received04/19/2019
Supplement Dates FDA Received05/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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