MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 CLOSED WOUND SUCTION EVACUATOR, 100ML SILICONE EVACUATOR WITH ANTI-REFLUX VALVE,

Catalog Number 0070740

Device Problems Decrease in Suction (1146); Device Inoperable (1663); Device Operates Differently Than Expected (2913)

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

Event Date 01/17/2017

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 device would not suction.After open surgery of the lower abdomen (sigmoid colon), a channel drain was placed in the lower abdomen and the wound was closed.Subsequently, he connected an evacuator to the channel drain and attempted to suction; however, no suction could be established.The evacuator was replaced with a second evacuator (same catalog number), and he attempted to suction again; however, the attempt failed.The patient's wound was reopened, and the channel drain was and replaced.After the second channel drain was connected, to the second evacuator, suction was established.There has been no further patient injury reported to date.These procedures were performed in the same operating room.

Manufacturer Narrative

Received 1 used evacuator only.Per the visual evaluation, no defects on the evacuator were noted.Per the functional evaluation, a suction test was performed.A channel drain was connected to the inlet port of the evacuator and the drain end was submerged in water.The evacuator was compressed and rolled over, which was kept compressed by hand, and then, the outlet port was closed.The evacuator suctioned 100cc of water without any difficulties.In addition, it was noted that the evacuator recovered its original shape once it suctioned.The reported event was unconfirmed as the reported problem could not be reproduced.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).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 device would not suction.After open surgery of the lower abdomen (sigmoid colon), a channel drain was placed in the lower abdomen and the wound was closed.Subsequently, he connected an evacuator to the channel drain and attempted to suction; however, no suction could be established.The evacuator was replaced with a second evacuator (same catalog number), and he attempted to suction again; however, the attempt failed.The patient's wound was reopened, and the channel drain was and replaced.After the second channel drain was connected, to the second evacuator, suction was established.There has been no further patient injury reported to date.These procedures were performed in the same operating room.

Manufacturer Narrative

Received 1 used evacuator only.Per the visual evaluation, no defects on the evacuator were noted.Per the functional evaluation, a suction test was performed.A channel drain was connected to the inlet port of the evacuator and the drain end was submerged in water.The evacuator was compressed and rolled over, which was kept compressed by hand, and then, the outlet port was closed.The evacuator suctioned 100cc of water without any difficulties.In addition, it was noted that the evacuator recovered its original shape once it suctioned.The reported event was unconfirmed as the reported problem could not be reproduced.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: ensure that the wound site is dry and free of debris before closure.The surgeon must determine the number of drains needed for an effective drainage of the entire wound site.The junction between the tubing and tissue at the drain entrance site must be air-tight for effective functioning of the system.If the drain is occluded, irrigation and/or aspiration of the drain may be required.The quality and quantity of drained fluid must be regularly monitored and reported to the surgeon.Reservoir, once full, must be emptied per hospital protocols.Failure to do so will result in incomplete drainage.Suction must be discontinued prior to the removal of the drain.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: 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." (b)(4).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 device would not suction.After open surgery of the lower abdomen (sigmoid colon), a channel drain was placed in the lower abdomen and the wound was closed.Subsequently, he connected an evacuator to the channel drain and attempted to suction; however, no suction could be established.The evacuator was replaced with a second evacuator (same catalog number), and he attempted to suction again; however, the attempt failed.The patient's wound was reopened, and the channel drain was and replaced.After the second channel drain was connected, to the second evacuator, suction was established.There has been no further patient injury reported to date.These procedures were performed in the same operating room.

• Brand Name: CLOSED WOUND SUCTION EVACUATOR, 100ML SILICONE EVACUATOR WITH ANTI-REFLUX VALVE,
• Type of Device: EVACUATOR
• 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: 6312595
• MDR Text Key: 67232439
• Report Number: 1018233-2017-00363
• Device Sequence Number: 1
• Product Code: GCY
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 0070740
• Device Lot Number: NGAR4109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2016
• 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
• Patient Outcome(s): Required Intervention