MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 RELIAVAC 400 CLOSED WOUND SUCTION KIT; RELIA VAC

Catalog Number	0034630
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2017
Type of Reportable Event	Malfunction
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 balloon burst during patient use.The user said that they did not apply excessive pressure to the balloon, and no injury was reported.
Additional Manufacturer Narrative
The reported issue was confirmed.The device was returned for evaluation.Visual inspection found the balloon burst.Unable to determine root cause of burst balloon.May be due to the dipping operation of manufacturing.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use state the following: "vi.Warnings: 1.An effective closed suction drain system requires maintenance of the system to preserve patency.The drain must not be allowed to occlude nor the reservoir to completely fill; and reservoir must be maintained in order for the system to function properly.If the system is not maintained properly, surgical complications including hematomas may result.2.Blood collected using the evacuator must not be re-infused as it may be a cause of potential infections.3.Do not use in patients who are allergic to materials used in bard® drain products.4.Do not bypass or inactivate the anti-reflux valve.5.In the event of occlusion of the drain, all wound drainage ceases.Careful attention to the drain will minimize the probability of this problem.If occlusion does occur, the drain can be aspirated by connecting auxiliary suction to the reservoir outlet or temporarily disconnecting the drain from the evacuator and applying auxiliary suction directly to the drain.6.If an air-tight seal between the drain and the skin (from where the drain emerges) is not achieved, then air leak must be rectified or the system must be converted to open drainage.7.An airtight seal between all system components (drain, adapter, y-connector, crab-claw, evacuator and tube ends) is necessary for intended system function.8.Leaving the drain implanted for any period of time so as to cause tissue ingrowth around the drain can interfere with easy removal and may affect the performance of the drain.The surgeon should monitor the patient¿s rate of wound healing.9.Drain perforations must lie within the wound or cavity to be drained, otherwise inadequate drainage may result.10.To avoid the possibility of drain damage or breakage, please follow these steps: a.Avoid suturing through drains.B.Drains should lie flat and in line with the skin exit areas.C.Particular care should be taken to avoid any obstacles to the drain exit path.D.Drains should be checked for free motion during closure to minimize the possibility of breakage.E.Drain removal should be done gently by hand.Drains should not be handled with pointed, toothed or sharp instruments as these could cause cuts or nicks and lead to subsequent structural failure of the drain.F.Surgical removal may be necessary if drain is difficult to remove or breaks.11.This is a single use device.Do not reuse.12.Do not re-sterilize." (b)(4).
Event or Problem Description
It was reported that the balloon burst during patient use.The user said that they did not apply excessive pressure to the balloon, and no injury was reported.

• Brand Name: RELIAVAC 400 CLOSED WOUND SUCTION KIT
• Common Device Name: RELIA VAC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6898416
• Report Number: 1018233-2017-05018
• Device Sequence Number: 1408657
• Product Code: GCY
• UDI-Device Identifier: 00801741049149
• UDI-Public: (01)00801741049149
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0034630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Initial Date Received by Manufacturer: 09/08/2017
• Supplement Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 09/27/2017
• Supplement Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1