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

Catalog Number 4008

Device Problem Biocompatibility (2886)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Swelling/ Edema (4577)

Event Date 07/28/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, a patient coursing chemotherapy was indicated for picc tube placement, to reduce the incidence of phlebitis and other adverse reactions to chemotherapy infusion.On (b)(6) 2023, an iv3000 1 hand 10x12cm ctn 50 on the picc catheter was exchanged, the next day the patient's picc tube film was found to have obvious redness and swelling.So the patient's skin was treated with disinfection, wet compresses of dexamethasone sodium phosphate injection, and dicloxacillin anti-allergy.

Manufacturer Narrative

H3, h6: it was reported that, a patient coursing chemotherapy was indicated for picc tube placement, to reduce the incidence of phlebitis and other adverse reactions to chemotherapy infusion.On (b)(6) 2023, an iv3000 1 hand 10x12cm ctn 50 on the picc catheter was exchanged, the next day the patient's picc tube film was found to have obvious redness and swelling.So the patient's skin was treated with disinfection, wet compresses of dexamethasone sodium phosphate injection, and dicloxacillin anti-allergy.The device was not returned for evaluation.We have therefore not been able to confirm a relationship between the event and the device or identify a definitive root cause.The risk management documentation for iv3000 has been reviewed to assess whether the alleged failures and associated harm has been anticipated.Reaction to the dressing is anticipated, the product has been used on patients with fragile/sensitive skin or has a dermatological condition, patients reaction is probable, this is considered as acceptable (with no impact to the risk file ratings).A lot number was provided, and the batch records were reviewed.It was confirmed that the product(s) 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.The probable cause remains unknown.Factors may include patient sensitivity; that the patient was sensitive to one or more of the components of the dressing, or that there was a pre-existing or concurrent medical condition that led to the reported event.A further cause or contributing factor may be that the patient's skin has not been adequately prepared prior to the dressing being applied (or the patient was sensitive to any product(s) used in the course of such preparation), or that the dressing had not been changed at suitable intervals, aggravating the patient's skin as a result.

• 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 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 ; 5123913905
• MDR Report Key: 18171473
• MDR Text Key: 328548850
• Report Number: 8043484-2023-00083
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223417406
• UDI-Public: 05000223417406
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

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: 2240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention