MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 CLOSED WOUND SUCTION 100ML SILICONE EVACUATOR, HUBLESS SILICONE FLAT DRAIN, 7MM; FLAT SILICONE DRAIN

Catalog Number	0071430
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential failure mode could be 'holes too big¿ with a potential root cause of 'wear tooling.¿ the lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿important: check for fluid entering closed wound suction evacuator.Lack of flow may indicate all exudate has been removed.Check all connections for air leaks and wound tube perforations for exposure above skin.Several activations of the closed wound suction evacuator may be required to establish suction because of: air entering partially closed wound; an operative air pocket.The attached strap may be used to secure the evacuator to the patient.Precautions: avoid suturing through the drains to minimize the possibility of breakage.Drains should lie flat and in line with the skin exit path.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 during/after removal.Drain removal should be done gently by hand.Drains should not be handled with pointed, toothed or blunt instruments which could cause cuts or nicks and lead to subsequent structural failure of the drain.Warning: drain breakage may require surgical removal.".
Event or Problem Description
It was reported that when the drain was being removed postoperatively it broke; there were pieces left inside of the patient resulting in the patient having to go back to surgery.It was also reported that the drain was inserted on (b)(6) 2019 and removed on (b)(6) 2019.

• Brand Name: CLOSED WOUND SUCTION 100ML SILICONE EVACUATOR, HUBLESS SILICONE FLAT DRAIN, 7MM
• Common Device Name: FLAT SILICONE DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8788937
• Report Number: 1018233-2019-03887
• Device Sequence Number: 2540433
• Product Code: GCY
• UDI-Device Identifier: 00801741049668
• UDI-Public: (01)00801741049668
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/15/2019

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 Catalogue Number: 0071430
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 07/15/2019
• 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