MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 CWS 400 CLOSED WOUND SUCTION KIT, PVC DRAIN; 3 SPRING EVACUATOR

Catalog Number 0043610

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

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 there was clotting in the end of the tubing that connects to the suction port.There was no patient impact.The device was replaced and worked without issue.

Manufacturer Narrative

Received 1 used closed wound suction evacuator with the wound drain attached.Visual inspection noted no obvious defects.The sealing of the evacuator was adequate and there was no occlusion observed in the suction port, drain or tubing.The following functional test was performed: attach tubing with y- connector (in house) to evacuator.An in house tubing was used as the sample tubing presented with foreign material inside of it; submerge the drain in 500 cc of water; insert free end of evacuator y-tubing into evacuator suction port a; fully compress evacuator by hand and close drain port b; during this test the evacuator suctioned 350cc of water.The following leak test was performed: the evacuator was filled with water and blue methylene; during this test no leakage was found.The following test was performed to verify whether there was an occlusion within the drain or tubing: the tubing and drain was filled with water and blue methylene; during this test it was observed that water flowed freely through the tubing and drain; no occlusion was observed.A dimensional evaluation was performed and it was found that the device was within specifications.The lot number is unknown therefore the device history record could not be reviewed.The complaint was unconfirmed as the problem could not be reproduced.The instructions for use state the following: "v.Precautions: 4.If the drain is occluded, irrigation and/or aspiration of the drain may be required.Vi.Warnings: 5.In the event of occlusion of the drain, all wound drainage ceases.Careful attention to the drain will minimize the probability of this problem.If occlusion does occur, the drain can be aspirated by connecting auxiliary suction to the reservoir outlet or temporarily disconnecting the drain from the evacuator and applying auxiliary suction directly to the drain." (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.

Manufacturer Narrative

The functional assessment found that the evacuator only suctioned 200cc's of water.The evacuator showed signs of usage and it was found that the suction port and drainage tubing had foreign material related to usage.The foreign material appeared to be blood.The complaint was confirmed with an unknown root cause.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.

• Brand Name: CWS 400 CLOSED WOUND SUCTION KIT, PVC DRAIN
• Type of Device: 3 SPRING 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: janna parks ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5410994
• MDR Text Key: 37837982
• Report Number: 1018233-2016-00088
• Device Sequence Number: 1
• Product Code: GCY
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0043610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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