MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS TCH 300ML CANISTER; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	66801273
Medical Device Problem Codes	Difficult to Open or Close (2921); Sharp Edges (4013)
Health Effect - Clinical Code	Localized Skin Lesion (4542)
Date of Event	04/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that when changing the canister, the renasys tch 300ml canister was very difficult to open and the taps were very sharp.A smith and nephew back up device was available.The nurse cut himself when opening the canister tabs.No other complications reported.
Additional Manufacturer Narrative
H3, h6: the device, intended for use in treatment, was not returned for evaluation.A photo was provided for review and we have not been able to establish a relationship between the device and the reported event or determine a root cause.Probable root cause may be a component machining error which created a sharp edge on the device.As no lot number was provided, a dhr review could not be performed.A complaint history review was performed and showed one further similar incident.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device.The associated risk files contain the reported failure/harm or event.The investigation is now complete.This failure is considered to be an isolated event therefore no further action is deemed necessary at this stage.Smith + nephew will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: RENASYS TCH 300ML CANISTER
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11822012
• Report Number: 8043484-2021-01133
• Device Sequence Number: 11633339
• Product Code: OMP
• UDI-Device Identifier: 00040565126524
• UDI-Public: 00040565126524
• Combination Product (Y/N): N
• PMA/510(K) Number: K153209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 66801273
• Device Catalogue Number: 66801273
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other