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

Catalog Number	0034610
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/07/2019
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.
Event or Problem Description
It was reported that the balloon of the reliavac could not be inflated on the day of use.
Additional Manufacturer Narrative
The reported event was unconfirmed, since the reported failure could not be reproduced.The device could not be used for treatment due to the reported failure.The device did not have explicit specifications for balloon inflation, however inflated as intended.Visual evaluation of the sample noted one used reliavac within opened original packaging.Concomitant, in-house evacuator tubing was attached to port a of the evacuator.The other end of the tubing was placed in a reservoir of water.Evacuator balloon was inflated by engaging the bulb at the top of the device.The balloon was fully inflated with no difficulty and was able to fully expand as intended.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: ¿vii.Instructions for use: the surgeon should irrigate the wound with sterile fluid, and then suction the irrigating fluid and gross debris from the operative site.Tubes should lie flat and in line with the anticipated skin exit.To facilitate later removal by manual traction, the tubing should not be curled, pinched, or sutured internally.Positioning of the drain in the body cavity, as well as the number of drains indicated, should be determined by the surgeon.Drain tubing should be placed within the wound by approximating the areas of critical fluid collection.Care must be taken to ensure that all drain perforations or channels lie completely within the wound or cavity to be drained.Taping or a triple loop suture (around and not through the tubing) will aid in preventing accidental drain placement.Deep drainage is best accomplished by using one or more drains for each level of tissue.Each level should be evacuated by a separate vacuum source.Care must be exercised to avoid damage to the drain (refer to warnings).The tubing should be repeatedly checked during closure for free motion to avoid breakage and/or fragment retention within the wound.When using a trocar please follow these instructions: 9.I.) with one drain: draw drain using trocar from inside to outside of wound.Ensure that perforated section of the drain is within the critical fluid collection areas of wound.Remove trocar only by cutting the drain one inch from end of trocar.Trim non-perforated section of drain to desired length.Attach non-perforated section of drain either to an evacuator inlet port or to a y-connector.9.Ii.) with two single drains: follow instruction# 9(i) for each of the two drains separately.9.Iii.) with a double drain: draw drain using trocar from inside to outside of wound.Ensure that desired perforated region of the drain is within the critical fluid collection areas of wound.Cut the outer portion of the drain (outside the wound area) in the middle of the perforated region.".
Event or Problem Description
It was reported that the balloon of the reliavac could not be inflated on the day of use.

• Brand Name: RELIAVAC 400 CLOSED WOUND SUCTION KIT
• Common Device Name: RELIAVAC KIT 400CC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9341026
• Report Number: 1018233-2019-07383
• Device Sequence Number: 438200
• Product Code: GCY
• UDI-Device Identifier: 00801741049125
• UDI-Public: (01)00801741049125
• 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: distributor,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2019

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 Expiration Date: 03/31/2022
• Device Catalogue Number: 0034610
• Device Lot Number: NGDQ0913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 12/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1