MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKN IV3000; TAPE AND BANDAGE, ADHESIVE

Catalog Number UNKNOWN

Device Problem Biocompatibility (2886)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Rash (2033); Blister (4537)

Event Date 12/22/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, during treatment with iv cannulation with a port inserted in (b)(6) 2021, the patient started experiencing reactions in the chest when using iv3000, although it seemed to be okay on the arms.Reactions, that typically include a red sunburn rash and then develop into hives and blisters, start within an hour after application.Such reactions disappear after a day of initial reaction, but blisters take a week or so.This is treated with benadryl and triamcinolone cream/ointment, as well as letting ir air out over covering blisters with gauze.Protocol for skin preparation has been wiping over site with alcohol and then typical iv preparation, although most recently skin prep wipes have been used here as it helps to keep cannula in place.Patient has had history of trouble with skin reacting to adhesives because of mast cell activation syndrome.Problem is ongoing.

Manufacturer Narrative

H10: it was reported that, during treatment with iv cannulation with a port inserted in (b)(6) 2021, the patient started experiencing reactions in the chest when using iv3000, although it seemed to be okay on the arms.Protocol for skin preparation has been wiping over site with alcohol and then typical iv preparation, although most recently skin prep wipes have been used here as it helps to keep cannula in place.Patient has had history of trouble with skin reacting to adhesives because of mast cell activation syndrome.The device was used for treatment and was not returned for analysis.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.As no lot number was provided it was not possible to carry out a device history review.A complaint history review revealed a small number of similar instances in the last three years.There is nothing to indicate that this is outside of acceptable rates of occurrence.The risk files, mitigate the reported issues with no updates required.A clinical assessment concluded that it is uncertain if the reaction the patient experienced is due to an allergy to medical adhesive or the result of a non-allergic irritation caused by one or more chemicals in the adhesive and that since the adverse event is ongoing, no further assessment is warranted at this time.Probable root cause is incorrect application of the dressing, infrequent dressing changes, an allergic reaction by the patient to one or more of the components of the dressing, or a non-allergic irritation to one or more chemicals in the adhesive.The users of the reported product are advised to consult the ifu, to help prevent future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device, including the correct application of dressing and frequency of dressing changes.This investigation is now complete, with no corrective actions required.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.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.Internal complaint reference number: (b)(4).

• Brand Name: UNKN IV3000
• 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: 13204935
• MDR Text Key: 283490240
• Report Number: 8043484-2022-00024
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/22/2021
• Initial Date FDA Received: 01/10/2022
• Supplement Dates Manufacturer Received: 04/14/2022
• Supplement Dates FDA Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: 420400-SKIN-PREP WIPES BOX 50 01
• Patient Outcome(s): Other
• Patient Sex: Female