MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. SKIN-PREP WIPES CTN 50; BANDAGE, LIQUID

Catalog Number 59420425

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2020

Event Type  Injury  

Event Description

It was reported that after surgery, skin prep was being used as preparation for the use of renasys touch npwt, the surgeon saw a small bleeding from a vessel and used diathermy device to burn/close the vessel while using skin prep.Operating room sheets caught fire while using diathermy device.All materials were taken off the patient due to a quick response from the operating nurses.The patient did not get injured and the therapy was continued normally later.

Manufacturer Narrative

We have now concluded our investigation into this complaint.The product, used in the treatment, was not returned for evaluation.As no sample was returned, visual and functional evaluation could not be performed and a relationship between the reported event and the product could not established.A batch record review was performed and it can be confirmed that the correct bulk and packing material was used to manufacture the product.There were not any issues found which could have contributed to this event.As per the release procedure, the batch released to market undergoes full testing as outlined in the finished product specification, and must comply with all the requirements.There have been no changes to the manufacturing process or raw materials used that may have caused or contributed to the incident highlighted in this complaint.A three-year complaint history review was completed and no other complaints were found.As per clinical evaluation: a thorough medical investigation was performed, the root cause of the reported fire is likely due to a user vs procedural event.The ifu does caution that the skin prep is flammable and to be used in a well-ventilated area and avoid using near flames or sources of ignition i.E.Electrocautery procedures.Do not apply to open wounds or mucous membranes.Since no patient harm is being alleged, no further assessment is warranted at this time.Review of the risk management file found all relevant hazards adequately identified in relation to the failure mode with residual risk mitigated to an acceptable level.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.

• Brand Name: SKIN-PREP WIPES CTN 50
• Type of Device: BANDAGE, LIQUID
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: sarah freestone ; 101 hessle road; hull HU3 2-BN ; UK HU3 2BN ; 0447940038
• MDR Report Key: 9861353
• MDR Text Key: 184316941
• Report Number: 8043484-2020-00185
• Device Sequence Number: 1
• Product Code: KMF
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K973228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 59420425
• Device Lot Number: 55520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention