MAUDE Adverse Event Report: GUANGZHOU WELL LEAD TUBING SUCTION 9/32''

Model Number N710

Device Problems Collapse (1099); Off-Label Use (1494)

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

Event Date 09/10/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history record review for the lot number reported did not indicate any exception that could lead to the reported incident.Collapse test on retained sample indicated that the product met the specified requirements.From the investigation the root cause could not be determined.No corrective action will be taken at this time.We will continue to monitor for any similar reports.Based on conversation with the hospital and sales rep it was determined that the incorrect tubing was being used from the wall to the canister.The hospital has been informed and is now using the correct product.

Event Description

Suction tubing is collapsing during use.The customer is using the incorrect product based on conversation with them.

• Brand Name: TUBING SUCTION 9/32''
• Type of Device: TUBING SUCTION 9/32''
• Manufacturer (Section D): GUANGZHOU WELL LEAD; c-4 jinhu industrial estate,; jualong, panyu; guangzhou 51143 4; CH 511434
• Manufacturer (Section G): GUANGZHOU WELL LEAD; c-4 jinhu industrial estate,; jualong, panyu; guangzhou 51143 4; CH 511434
• Manufacturer Contact: michele donatich ; 1500 waukegan road; waukegan, IL 60085 ; 8478876412
• MDR Report Key: 5178033
• MDR Text Key: 29931069
• Report Number: 1423537-2015-00070
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N710
• Device Catalogue Number: N710
• Device Lot Number: 15033139E-LSH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other