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 08/04/2020

Event Type  Injury  

Event Description

It was reported that on (b)(6), the skin around the puncture site was slightly itchy without redness and swelling.On (b)(6) 2020, it was found that the skin around the picc puncture site was red, with a size of 10 * 12cm, blistering and exudation, and complained of itchy skin.The skin was disinfected with iodophor, and the local skin was smeared with dexamethasone sodium phosphate injection (5mg).After maintenance, the transparent dressing was not used and fixed with sterile gauze and bandage.

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 complaint history review was carried out using the lot and part numbers provided, there have been no further complaints reported with this failure mode in the past three years.The device was used in treatment.As no samples were returned a product evaluation could not be carried out.A clinical investigation concluded; ¿no relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's current condition is unknown.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.¿ a risk management review was carried out which identified some potential causes for the reported issue.The risk files for this product contains multiple failure modes leading to type 4 sensitisation such as expired dressings, skin preparation treatments and patient allergy to components in the dressing.Without further information an accurate failure mode cannot be assigned.The ifu outlines steps for safe and proper application and care of the dressing and surrounding skin site.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.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 east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10505188
• MDR Text Key: 206083474
• Report Number: 8043484-2020-02775
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 04582111150998
• UDI-Public: 4582111150998
• Combination Product (y/n): N
• 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
• Report Date: 11/05/2020

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: 4008
• Device Lot Number: 1924
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 09/08/2020
• Supplement Dates Manufacturer Received: 11/29/2020
• Supplement Dates FDA Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention