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

Catalog Number UNKNOWN

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

Patient Problems Injury (2348); Unspecified Tissue Injury (4559)

Event Date 01/01/1901

Event Type  malfunction  

Event Description

It was documented on the paper "relationship between application permeability and contact dermatitis at central venous catheterization in tumor patients" that the transparent dressing - opsite post-op (smith & nephew, uk) was used in 56 patients to fixed catheters.After 56 patients were determined to be allergic to the dressing application, the dressing was changed into iv 3000 transparent dressing (smith & nephew), and dexamethasone injection was applied locally when necessary.Out of these, 6 patients were the treatment was ineffective, 4 patients recovered within 2 weeks after changing gauze dressings and for 2 patients is unknown if an additional medical intervention was necessary.

Manufacturer Narrative

H3, h6: we have now concluded our investigation for the complaint received.A review of the batch manufacturing records could not be performed as no part or lot numbers were provided, however, there are no indications to suggest that the device did not meet specifications upon release into distribution.The complaint history file contains further instances related events of the reported events.The device was intended for use in treatment.As no samples were returned, a product evaluation could not be carried out.Dressings should be changed around every 3 days but in some cases may be left in place for 7 days.If the adhesive integrity is compromised due to prolonged wear, the surgical site may be susceptible to external contamination.A clinical investigation concluded; the data provided is from a chinese article, "relationship between application permeability and contact dermatitis at central venous catheterization in tumor patients," that was presented already translated in a excel spreadsheet in english.The limited information provided did not provide insight or relevance to current clinical outcomes for the product/device.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should additional medical information be provided this complaint will be re-assessed.As the product code is unknown, a review of the device labelling could not be carried out.The associated risk file contains the reported event.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: UNKNOWN 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
• MDR Report Key: 10233875
• MDR Text Key: 197605616
• Report Number: 8043484-2020-01707
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 07/06/2020
• Supplement Dates Manufacturer Received: 01/19/2021
• Supplement Dates FDA Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other