MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000 1 HAND 10X12CM CTN 50; TAPE AND BANDAGE, ADHESIVE

Catalog Number 4008

Device Problem Insufficient Information (3190)

Patient Problem Skin Irritation (2076)

Event Date 11/18/2019

Event Type  Injury  

Event Description

It was reported that the patient presented an allergic reaction to the product.The problem was solved removing the dressing and disinfecting the area with 2% chlorhexidine gluconate, a dexamethasone injection was applied to the affected area.After that, the catheter was replaced with a fixed position, and the dressing was replaced with sterile gauze to cover the puncture site and surrounding skin.The skin was routinely sterilized.On (b)(6) 2019, the skin itching symptoms were relieved.The skin rash got better, some of the blisters were absorbed, and some of the broken blisters were scabbed.Also the skin temperature was normal.

Manufacturer Narrative

This was reported as a malfunction, but a medical intervention was required, due to that, this report was updated as an adverse event.

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 complaints history review was carried out using the lot and part numbers provided, there have been further complaints reported with this failure mode in the past three years.The device was used for treatment.The returned samples were evaluated.No visual or functional defects were identified with the returned samples.A clinical assessment was carried out.It was concluded that: ¿this case reports itching, burning, redness, and several small blisters following the use of the iv3000 dressing.The dressing was removed and the arm was treated with local disinfection, 2% chlorhexidine gluconate, dexamethasone injection, the catheter was replaced with a fixed position, and the dressing was replaced with sterile gauze.The following day the symptoms were alleviated.Undated photos have been provided for review and confirmed the reported event.The product was returned for evaluation and no issues were identified with returned samples.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).It was further communicated, however, that the iv3000 dressing was subsequently replaced and the issue resolved.Therefore, no further medical assessment is warranted at this time.A risk management review was carried out.The risk files for this product outline type 1 and type 4 sensitisation as a harm associated with general toxicity of the component materials included in the dressings, which could be a possible cause of the reported issue.The ifu was reviewed and no information was found that could have caused or contributed to this event.We have not been able to confirm a relationship between the event and the device.On this occasion we do not have sufficient evidence to determine 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 HU3 2 BN; UK HU3 2BN
• MDR Report Key: 9489580
• MDR Text Key: 172033360
• Report Number: 8043484-2019-00929
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4008
• Device Lot Number: 1827
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/18/2019
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 11/22/2019; 05/22/2020
• Supplement Dates FDA Received: 02/26/2020; 05/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR