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

Catalog Number 4008

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Irritation (2076)

Event Date 11/19/2019

Event Type  malfunction  

Event Description

It was reported that the skin on the right upper arm was itching, burning, redness (an area about 0.5cm*4cm), and several small blisters, for which some of the blisters have burst.Skin temperature rises.To treat this event was necessary to remove the dressing immediately, applied local disinfection with 2% chlorhexidine gluconate, apply dexamethasone injection to the affected area, change the catheter fixation position, replace the dressing with sterile gauze to cover the puncture site and surrounding skin and fix it with elastic bandage.3.On (b)(6) 2019, the skin itching symptoms were alleviated, some of the blisters had been absorbed, some of the broken blisters had crusted, and the skin temperature was normal.

Manufacturer Narrative

We have now concluded our investigation for the complaint received.A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant.In addition it can be confirmed that all finished product specification testing was satisfied at the point of release.A complaints history review was carried out using the lot and part numbers provided, there have been further complaints reported with this issue in the past three years.The device was used for treatment.It was reported that during use an adverse skin reaction to the local skin site was experienced.The returned samples were assessed.A visual and functional evaluation found no abnormalities or issues.Images provided confirmed the failure mode.A clinical assessment was made.It was concluded; ¿this case reports itching, burning, redness, and several small blisters following the use of the iv3000 dressing.The dressing was removed and the arm was treated with local disinfection, 2% chlorhexidine gluconate, dexamethasone injection, and replacement of the dressing with sterile gauze and elastic bandages.The following day the symptoms were alleviated.Undated photos have been provided for review.The information provided is insufficient to determine whether the patient¿s symptoms are due to a pre-existing or concurrent medical condition (allergy history, skin/dermal sensitivities).It was further communicated, however, that the iv3000 dressing was subsequently replaced and the issue resolved.Therefore, no further medical assessment is warranted at this time.¿ a risk management review was carried out.The risk files for this product contain several causes of allergic reactions leading to type 4 sensitisation, and allergic contact dermatitis such as lifting of the dressing from the skin or use of the product that conflicts with the ifu.As stated in the ifu for this product, 'do not stack dressings, or allow dressings to overlap.Periodically monitor the dressing and catheter site to confirm secure attachment and continued proper infusion, especially after bathing, showering, or if the dressing and catheter site becomes wet.' if the ifu is not directly followed, adverse events may occur.We have not been able to confirm a definitive root cause on this occasion or confirm a relationship between the reported event and the device.Should further information become available this case may be reassessed.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.

• 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 HU3 2 BN; UK HU3 2BN
• MDR Report Key: 9497840
• MDR Text Key: 177399641
• Report Number: 8043484-2019-00935
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/12/2020

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
• Device Operator: No Information
• Device Catalogue Number: 4008
• Device Lot Number: 1827
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 03/05/2020
• Supplement Dates FDA Received: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR