MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 DAVOL SILICONE ROUND SINGLE DRAIN; WOUND DRAIN

Catalog Number	0070230
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)
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 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.
Additional 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 or Problem 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.

• Brand Name: DAVOL SILICONE ROUND SINGLE DRAIN
• Common Device Name: WOUND DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8524423
• Report Number: 1018233-2019-02005
• Device Sequence Number: 16615660
• Product Code: GBX
• UDI-Device Identifier: 00801741049453
• UDI-Public: (01)00801741049453(10)
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 0070230
• Device Lot Number: NGCW0361
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 05/31/2019
• 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: Hospitalization; Required Intervention