MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS 10MM FLAT DRAIN A KIT; DRESSING,WOUND,OCCLUSIVE

Model Number	66801752
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during npwt, a renasys touch and flat drain kit, showed the message of blockage alarm displayed on the screen.The problem was not solved by exchanging the softport.The doctor decided to use only the soft port for treatment.The drainage kit is used and discarded.No patient was harmed.
Additional Manufacturer Narrative
Additional information was received that identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.

• Brand Name: RENASYS 10MM FLAT DRAIN A KIT
• Common Device Name: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire
• MDR Report Key: 11813828
• Report Number: 8043484-2021-01091
• Device Sequence Number: 14401179
• Product Code: NAD
• UDI-Device Identifier: 05000223488444
• UDI-Public: 05000223488444
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/21/2021

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: Health Professional
• Device Expiration Date: 04/09/2022
• Device Model Number: 66801752
• Device Catalogue Number: 66801252
• Device Lot Number: 33019E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1