MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000 SHAPED 12X9CM CTN 50; TAPE AND BANDAGE, ADHESIVE

Catalog Number 66004009

Device Problems Detachment of Device or Device Component (2907); Material Integrity Problem (2978)

Patient Problems Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2020

Event Type  malfunction  

Event Description

It was reported that during an infusion foil in the neck, the site where the treatment was being performed close to the jugular is detached from the skin.No problems on the non-woven part, always on the film.The product detached within 24 hours.Sometimes the picc line is exposed.Products are difficult to apply to a restless patient.Impossible to handle with 1 hand.No patient harm reported.A competitor product was used to continue the treatment.

Manufacturer Narrative

H10.H3, h6: 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 review found further instances of the reported event in the past years.The device was used for treatment.No samples were returned for evaluation.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.A clinical investigation concluded: ¿a review of this complaint case revealed there were no patient injuries reported.Per communication, less than 24 hours into the use of the iv3000 the film ¿detached from the skin.¿ photos of the device in use were provided for review and confirms the reported.The patients were treated with a competitor product and have since been discharge.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.¿ the instructions for use provides comprehensive instructions of the operation, use and limitations of the device.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 + nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: IV3000 SHAPED 12X9CM 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: 10782954
• MDR Text Key: 214509781
• Report Number: 8043484-2020-03626
• Device Sequence Number: 1
• Product Code: KGX
• 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
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66004009
• Device Lot Number: 2024
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1