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

Model Number	66024007
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Local Reaction (2035); Skin Tears (2516)
Date of Event	06/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after insulin pump therapy, the patient started experiencing redness and skin stripping about a couple of months ago.Patient uses skin-prep wipes to prepare for cannulation site and iv3000 1 hand 6x7cm to fixate the catheter and protect insertion site, so this adverse event could have been caused by either.Patient, who has been using our products for about 20 years, also claims that quality of such products has decreased recently, so they are not fulfilling their function to protect skin as they should.It is unknown how the patient has been alleviating/treating the injured skin.
Additional Manufacturer Narrative
It was reported that, after insulin pump therapy, the patient started experiencing redness and skin stripping about two months ago.Patient uses skin-prep wipes to prepare for cannulation site and iv3000 1 hand 6x7cm to fixate the catheter and protect insertion site, so this adverse event could have been caused by either.Patient, who has been using our products for about 20 years, also claims that quality of such products has decreased recently, so they are not fulfilling their function to protect skin as they should.Patient is now using no sting skin-prep products so the area affected area has improved and patient is now satisfied.The device was used for treatment and was returned for analysis.The returned samples showed no issues and functioned as expected.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.The batch records were reviewed and it could be confirmed that the products had progressed through a satisfactory release process which involved testing the product against the requirements of the finished product specification.There was also no issue identified during the manufacturing process that could have caused or contributed to the complaint problem.A complaint history review revealed a small number of similar instances in the last three years.A risk management review concluded that the sequence of events described in this complaint are not contained in the relevant risk files.There is insufficient information within the complaint description and further information included in this complaint to provide a causal link between events and the product therefore no update to the risk files is warranted.A clinical review concluded that the information provided is insufficient to determine whether the patient¿s symptoms, signs or outcome are due to a pre-existing or concurrent medical or surgical condition or procedure, or to an adverse reaction to or experience with the device, one or more of its components, or its intended therapeutic action.Probable root cause is that the patient experienced an allergic reaction to one of the components in the devices.As it states that the patient saw an improvement when changing to the non-sting skin preparation wipes, it is likely that the reaction was to the skin preparation wipes rather than the iv3000.The users of the reported product are advised to consult the ifu, to prevent future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device, including advice on skin preparation.This investigation is now complete, with no corrective actions required.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 internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
The device was used in treatment was not returned for evaluation, with all information provided we have not been able to establish a relationship between the device and the reported event or determine a root cause.Probable root cause may include patient sensitivity to product.The manufacturing records show no evidence that the product did not meet the specification at the time of manufacture.A complaint history review found further instances of the reported event.The associated risk files contain details relating to harm.However, the clinical review has not established a causal link.Additional rmr is not required.Instructions for use contains recommendations and precautionary statements for proper use of product.This investigation is now complete with no further action deemed necessary.Smith and nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: IV3000 1 HAND 6X7CM CTN 100
• Common Device Name: 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 12057851
• Report Number: 8043484-2021-01552
• Device Sequence Number: 4203116
• Product Code: KGX
• UDI-Device Identifier: 05000223417383
• UDI-Public: 05000223417383
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2022
• Device Model Number: 66024007
• Device Catalogue Number: 66024007
• Device Lot Number: 1939
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 10/15/2021; 05/11/2022
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 10/15/2021; 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Sex: Female