MAUDE Adverse Event Report: DRAINS

Device Problems Material Integrity Problem (2978); Packaging Problem (3007)

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

Event Type  Other  

Event Description

Drain tubing is vulnerable to breakage when the integrity is compromised by a small nick or cut.The drain has no markings.The ends of the tubing should be marked by a color or other mark to serve as a visual cue.If one does not see the mark upon removal of the drain, then one is aware the drain has been unintentionally cut or accidentally broken.The drain has no incremental measurement markings.There should be an incremental measurement marking for a quick reference on how much of the drain was cut off and how much remains.There are no warnings or precautions with drain packaging.A single quick reference label should be placed on the packaging with critical precautions on it such as: do not suture, do not overstretch, do not nick tubing and do not grasp at the edge.

• Brand Name: DRAINS
• Type of Device: DRAINS
• MDR Report Key: 5640778
• MDR Text Key: 44895144
• Report Number: MW5062147
• Device Sequence Number: 1
• Product Code: FFA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1