MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000 1 HAND 6X7CM CTN 100; TAPE AND BANDAGE, ADHESIVE

Catalog Number 4007

Device Problem Material Integrity Problem (2978)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

Complaint number: (b)(4).

Event Description

It was reported that a transparent dressing for intravenous injection was used in treatment for myocarditis in a pediatric patient but it was found that the dressing was not sticky.The nurse immediately stopped using it and replaced with another one.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Corrected: d4.

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.The complaint history file contains no further instances/ related events of the reported event.The device was used for treatment.As no samples were returned a thorough product evaluation could not be carried out.Low adhesion may be caused by adhesion levels of the raw material used to make the film of this dressing.There are various controls in place during the manufacturing process of both the raw material and the dressing to identify when the adhesion is not in acceptable range, as per the product specification.There are also regular tests carried out to monitor the finished product.As with all adhesive products, the skin site must be thoroughly cleaned and dried prior to application.If there is any moisture on the skin surrounding the catheter, the adhesive performance of this dressing may be compromised.If the dressing becomes wet whilst applied, it may have to be removed and a new dressing applied.We have not been able to confirm a relationship between the event and the device.The root cause remains undetermined.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 6X7CM CTN 100
• 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: 10877023
• MDR Text Key: 217441656
• Report Number: 8043484-2020-03951
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223417383
• UDI-Public: 05000223417383
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2020

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: Health Professional
• Device Catalogue Number: 4007
• Device Lot Number: 1830
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 11/23/2020; 11/23/2020
• Supplement Dates FDA Received: 12/03/2020; 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 13 YR