MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000 1 HAND 10X12CM CTN 50; TAPE AND BANDAGE, ADHESIVE

Model Number 66024008

Device Problem Biocompatibility (2886)

Patient Problems Blister (4537); Skin Inflammation/ Irritation (4545)

Event Date 08/28/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, a right thoracic drainage tube was placed on the patient, two days later the skin at the edge of one (1) iv3000 1 hand 10x12cm ctn 50 was found red.The dressing was replaced, and four days later, blisters were scattered around.The next day, the blisters had ruptured, that same day, patient underwent chest ct examination and the pleural effusion was reduced.The thoracic drainage and the film were removed according to the doctor's advice.Lyophilized recombinant human acidic fibroblast growth factor for external use was applied.Current patient's health status is unknown.

Manufacturer Narrative

Section h3, h6: it was reported that, a right thoracic drainage tube was placed on the patient, two days later the skin at the edge of one (1) iv3000 1 hand 10x12cm ctn 50 was found red.The dressing was replaced, and four days later, blisters were scattered around.The next day, the blisters had ruptured, that same day, patient underwent chest ct examination and the pleural effusion was reduced.The thoracic drainage and the film were removed according to the doctor's advice.Lyophilized recombinant human acidic fibroblast growth factor for external use was applied.Current patient's health status is unknown.The device was not returned for analysis.We have therefore not been able to confirm a relationship between the event and the device, or identify a definitive root cause.A lot number for the device was not provided, therefore it was not possible to carry out a device history review.A complaint history review (chr) revealed a small number of similar instances in the last 12 months.There is nothing to indicate this is outside of acceptable rates of occurrence.A clinical/medical evaluation was conducted, and was unable to rule out a procedural variance as a contributing factor to the reported event, rather than the device itself not functioning correctly.The iv3000 standard should be used on iv sites only.If a film dressing is required for open wounds such as pressure sores, burns, or donor sites, opsite flexigrid should be used.The health status of the patient is unknown, therefore the impact to the patient beyond that which has already reported cannot be confirmed nor concluded.Consequently, no further clinical/medical assessment is warranted at this time.A risk management review was conducted and which mitigated the reported issue with no further action or updates required.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device, including specific direction that the product should only be used on iv sites and precautionary advice where sensitive/fragile skin is an issue.A review of records held concluded that there are no prior escalated actions related to this product and the reported event.The probable root cause for this complaint is that the patient's skin was sensitive to one or more of the components of the dressing, leading to the reaction as reported in the complaint detail.Existing skin condition(s) might also be a contributing factor, as could the choice of dressing for the intended purpose.The users of the reported product are advised to consult the relevant ifu, to prevent future occurrences of the reported issue.Investigations into this matter are now complete.No further actions by smith & nephew are deemed necessary at this stage.However, we 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.H6: health effect - impact code.

• Brand Name: IV3000 1 HAND 10X12CM CTN 50
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16134889
• MDR Text Key: 307062228
• Report Number: 8043484-2023-00007
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223417406
• UDI-Public: 05000223417406
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

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
• Device Operator: Health Professional
• Device Model Number: 66024008
• Device Catalogue Number: 4008
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2022
• Initial Date FDA Received: 01/10/2023
• Supplement Dates Manufacturer Received: 03/17/2023
• Supplement Dates FDA Received: 03/21/2023
• 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