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

Model Number	T0449-01
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	05/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device had a fluctuating pressure, causing extravasation on the patient.
Additional 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
• Common Device Name: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 7551143
• Report Number: 3003604053-2018-00084
• Device Sequence Number: 16187131
• Product Code: HIG
• UDI-Device Identifier: 04056702003678
• UDI-Public: (01)04056702003678(17)211130(10)4011667
• Combination Product (Y/N): N
• PMA/510(K) Number: K031616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 05/29/2018
• Supplement Report FDA Received Date: 07/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1