MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 SILICONE CHANNEL DRAIN WITHOUT TROCAR, 19 FR., ROUND HUBLESS, FULL FLUTED

Catalog Number V072230

Device Problem Incorrect Measurement (1383)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 Description

It was reported that the channel drain was larger than usual.Allegedly appeared to be 24fr, instead of 19fr.The drain was removed and replaced during the initial procedure.It was later reported that there was no prolongation of the procedure.

Manufacturer Narrative

Received 5 lot samples for evaluation.The reported event was confirmed as manufacturing related.The visual inspection noted no obvious defects.Per the dimensional evaluation, the five samples were measured with french scale and optical comparator and the five samples were confirmed to correspond to one piece channel drain 24fr.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: "reorder #: drain size: drain shape: fluting: trocar depth indicator: v072230, 19 fr.Round hubless, full, ¿, dot.V072234, 24 fr.Round hubless, full, ¿, dot.For use with 100cc, 200cc, 400cc, and 3-spring evacuators.Indications: round silicone channel drains are indicated for use with selected evacuators for closed wound drainage following head and neck, orthopedic, abdominal, ent, ob/gyn, plastic, neurosurgery, thoracic and cardiovascular (channel drains only) procedures.Complications: 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 patients degree of intolerance to any foreign object in the body.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 or if the reservoir is not activated properly, doesn¿t function properly or is not monitored.Evacuators should be emptied and re-activated when required per hospital protocol.In the event an air-tight seal is not achieved, the reservoir will rapidly fill with air from the leak; subsequent drainage to the reservoir will occur only if allowed by gravity and wound exudate forcing the flow.Entry into the reservoir is allowed only by displacement of air in the reservoir by wound exudate flow.In this displacement process, air reflux from the reservoir 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 via the drain ceases.If the reservoir is not emptied when it is full, equilibrium between the drain and reservoir at wound pressure will ultimately occur and drainage from the wound site will cease.When the reservoir and drain are at the same pressure and the reservoir is full of fluid, the likelihood of back-contamination across the anti-reflux valve is increased.When used to drain the pleural cavity in the presence of an air leak, drains must be attached to an appropriate pleural cavity drainage system to prevent tension pneumothorax.Drain placement: the surgeon should irrigate the wound with sterile fluid, 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 operating 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 displacement.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 (see 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 Description

It was reported that the channel drain was larger than usual.Allegedly appeared to be 24fr, instead of 19fr.The drain was removed and replaced during the initial procedure.It was later reported that there was no prolongation of the procedure.

• Brand Name: SILICONE CHANNEL DRAIN WITHOUT TROCAR, 19 FR., ROUND HUBLESS, FULL FLUTED
• Type of Device: CHANNEL DRAIN
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6577266
• MDR Text Key: 75629484
• Report Number: 1018233-2017-02491
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: V072230
• Device Lot Number: NGAZ3014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1