MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 RELIAVAC 100 CLOSED WOUND SUCTION EVACUATOR

Catalog Number	0070900
Health Effect - Clinical Code	No Code Available (3191)
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.
Event or Problem Description
It was reported that the tubing disconnected from the bulb and resulted in blood getting on the patient.The complainant reported that the nursing staff attempted to use tape to adhere the tubing to the bulb prior to replacing the product.
Additional Manufacturer Narrative
The reported issue (it was reported that the tubing disconnected from the bulb and resulted in blood getting on the patient.The complainant reported that the nursing staff attempted to use tape to adhere the tubing to the bulb prior to replacing the product), was confirmed as cause unknown.During the visual evaluation no obvious defects were noticed in the received sample.According to the evaluation the sample was found within specification.The dimensional test was not performed on the drain that was received, as the part number was unknown in order to know its specifications.In the functional evaluation the drain was tested in the bulb and it was observed that the drain was loose.No other tests were performed to the received sample.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: ¿precautions: 1.Ensure that the wound site is dry and free of debris before closure.2.The surgeon must determine the number of drains needed for an effective drainage of the entire wound site.3.The junction between the tubing and tissue at the drain entrance site must be air-tight for effective functioning of the system.4.If the drain is occluded, irrigation and/or aspiration of the drain may be required.5.The quality and quantity of drained fluid must be regularly monitored and reported to the surgeon.6.Reservoir, once full, must be emptied per hospital protocols.Failure to do so will result in incomplete drainage.7.Suction must be discontinued prior to the removal of the drain.8.Before starting the drainage procedure, ensure that all the connections are tight and free of any obstructions within the drainage pathway.Connections to check are: i) drain to suction source.Ii) y-connector (when applicable): ¿ drain to y-connector ¿ y-connector to suction source.Instructions for use: 1.The surgeon should irrigate the wound with sterile fluid and then suction the irrigating fluid and gross debris from the operative site.2.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.3.Positioning of the drain in the body cavity, as well as the number of drains indicated, should be determined by the surgeon.4.Drain tubing should be placed within the wound by approximating the areas of critical fluid collection.5.Care must be taken to ensure that all drain perforations or channels lie completely within the wound or cavity to be drained.6.Taping or a triple loop suture (around and not through the tubing) will aid in preventing accidental drain placement.7.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.8.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." (b)(4).
Event or Problem Description
It was reported that the tubing disconnected from the bulb and resulted in blood getting on the patient.The complainant reported that the nursing staff attempted to use tape to adhere the tubing to the bulb prior to replacing the product.

• Brand Name: RELIAVAC 100 CLOSED WOUND SUCTION EVACUATOR
• Common Device Name: EVACUATOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7068198
• Report Number: 1018233-2017-06175
• Device Sequence Number: 1466342
• Product Code: GCY
• UDI-Device Identifier: 00801741049620
• UDI-Public: (01)00801741049620
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2018

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: 0070900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Initial Date Received by Manufacturer: 11/10/2017
• Supplement Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 01/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1