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

Catalog Number 0070900

Device Problems Device Damaged Prior to Use (2284); Material Deformation (2976)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that upon opening the package, the evacuator cap was found to be deformed.

Manufacturer Narrative

The reported event was confirmed.The device had not met specifications.The product was used for treatment purposes.The product was influenced by the reported failure.Visual evaluation of the housing valve assembly noted it was coming off of the bulb.A portion of the outlet nipple was slightly discolored with a rougher texture.The lip under the valve cover was slightly folded, which caused the housing valve assembly to come off easily.This was out of specification, which stated that the inspector was to verify that a bond exists between the "bulb to cover of valve assembly." 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: ¿vi.Complications: 1.This is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.2.Severe allergic reactions or illness may result in patients who are allergic to materials used in bard® drain products.3.If the evacuator is not emptied when full, drainage from the wound site will cease and the likelihood of back-contamination across the anti-reflux valve is increased.4.In the event an air-tight seal is not achieved, the evacuator will rapidly fill with air from the leak; subsequent drainage to the evacuator will occur only if allowed by gravity and wound exudates forcing the flow.Entry into the evacuator is allowed only by displacement of air in the evacuator by wound exudates flow.In this displacement process, air reflux from the evacuator to the wound can occur and increase the likelihood of back-contamination across the anti-reflux valve.In the event of drain occlusion by fibrin, clots, or other particulate matter, all wound drainage ceases.5.The advantages of wound drainage, particularly closed system drainage, are lost if an air-tight seal between the drain and the skin where the drain emerges is not achieved or if the drain is allowed to become occluded.6.Complications which may result from the use of this suction drainage system include the risks associated with methods utilized in the surgical procedure as well as the patient degree of intolerance to any foreign object in the body.Vii.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.9.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 the end of the 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." h11:section a through f - the information provided by bd 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 bd.

Event Description

It was reported that upon opening the package, the evacuator cap was found to be deformed.

• Brand Name: RELIAVAC 100 CLOSED WOUND SUCTION EVACUATOR
• Type of Device: 100CC SILICONE EVACUATOR BULB
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8868919
• MDR Text Key: 153974581
• Report Number: 1018233-2019-04532
• Device Sequence Number: 1
• Product Code: GCY
• UDI-Device Identifier: 00801741049620
• UDI-Public: (01)00801741049620
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 0070900
• Device Lot Number: NGCX1734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Date Manufacturer Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1