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

Catalog Number 66004009

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

Patient Problem Skin Irritation (2076)

Event Date 08/10/2020

Event Type  Injury  

Event Description

It was reported that after the treatment, it was found itchy, redness and blisters gradually.The internal jugular vein catheter was removed and local treatment was provided.After that, the symptom got better.Unknown if s&n backup device available.

Manufacturer Narrative

We have now concluded our investigation for the complaint received.A review of the batch manufacturing records could not be performed as no lot number was provided, however, there are no indications to suggest that the device did not meet specifications upon release into distribution.A complaint history review was carried out using the part number provided, there have been 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; ¿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).Per communications, the iv3000 subsequently was replaced and local treatment was provided to the site.Per report, the symptoms improved and the patient discharged from the hospital.It is unknown if a smith and nephew backup device was available to complete the procedure.Therefore, no further medical assessment is warranted at this time.¿ a risk management review was carried out which identified some potential causes for the reported issue.The risk files for this product contain 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.As stated in the ifu for this product, dressings and the surrounding skin site should be periodically monitored.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 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: 10518949
• MDR Text Key: 206476784
• Report Number: 8043484-2020-02832
• 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: 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: 66004009
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 10/29/2020
• 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