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

Model Number 66801273

Device Problems Difficult to Open or Close (2921); Sharp Edges (4013)

Patient Problems Laceration(s) (1946); Needle Stick/Puncture (2462)

Event Date 04/25/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, before npwt with five (5) renasys tch 300 ml canister.When changing the canister, the two orange tabs on the side of the canister were very difficult to open, so the nurse cut himself on the finger when opening the canister tabs as the taps were very sharp.It was unknown how the treatment was completed.The patient was not harmed.No further information available.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: the device, intended for use in treatment, was not returned for evaluation.All additional information provided was reviewed 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.

Event Description

It was reported that, before npwt with five (5) renasys tch 300ml canister.When changing the canister, the two orange tabs on the side of the canister were very difficult to open, so the nurse cut himself on the finger when opening the canister tabs as the tabs were very sharp.The nurse was fine and the small cut was only put on with a plaster and has healed well in the meantime.The treatment was successfully completed with the same device.Patient was not harmed.No further information available.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation.With all additional information provided we have not been able to establish a relationship between the device and the reported event or determine a root cause.Medical review concluded the patient¿s treatment was concluded with the same device and the patient was not harmed.The cut sustained by the nurse was treated with a plaster and healed.In addition, a procedural variance could not be ruled out as a contributing factor, based on the supplied information.The manufacturing records show no evidence that the products did not meet specifications at the time of manufacture.Complaint history review confirms related events, with no corrective action deemed necessary.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 event, and the probable root cause which may include the user pinching finger while closing canister.The investigation is now complete, smith + nephew will continue to monitor for any adverse trends relating to this product range.B5: updated description.D4: updated lot number.H6: updated codes.

• Brand Name: RENASYS TCH 300ML CANISTER
• Type of Device: 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: 11813624
• MDR Text Key: 250250995
• Report Number: 8043484-2021-01087
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00040565126524
• UDI-Public: 00040565126524
• Combination Product (y/n): N
• PMA/PMN Number: K153209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 66801273
• Device Catalogue Number: 66801273
• Device Lot Number: 46801470
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other