MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TUBE SET STERILE A127 PUMP; INSUFFLATOR, HYSTEROSCOPIC

Model Number T0449-01

Device Problem Pressure Problem (3012)

Patient Problem Extravasation (1842)

Event Date 05/16/2018

Event Type  malfunction  

Event Description

It was reported that the device had a fluctuating pressure, causing extravasation on the patient.

Manufacturer Narrative

Visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product to look at.As such the complaint is being closed without conclusion.

• Brand Name: TUBE SET STERILE A127 PUMP
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: jim ; arthrocare corporation; 7000 west william cannon drive; austin, 78735 united states
• MDR Report Key: 7551143
• MDR Text Key: 109570032
• Report Number: 3003604053-2018-00084
• Device Sequence Number: 1
• Product Code: HIG
• UDI-Device Identifier: 04056702003678
• UDI-Public: (01)04056702003678(17)211130(10)4011667
• Combination Product (y/n): N
• PMA/PMN Number: K031616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/30/2021
• Device Model Number: T0449-01
• Device Catalogue Number: T0449-01
• Device Lot Number: 4011667
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/16/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 07/17/2018
• Supplement Dates FDA Received: 07/18/2018
• Date Device Manufactured: 11/01/2016
• 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