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

Catalog Number 4008

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

Patient Problems Unspecified Infection (1930); Swelling (2091)

Event Date 04/08/2019

Event Type  Injury  

Event Description

It was reported that on (b)(6), in a patient with endometrial cancer that received radiotherapy, chemotherapy it was found a hardened mass about 10x20cm around the needle and also a small amount of pus was released from the needle puncture area.The mass was painful to touch, the arm above the elbow joint of the left arm was obviously swollen, and there was no abnormality in the right lower limb.The left upper limb was found to be thrombotic (partially closed).Blood test showed (b)(6) and anti-infection therapy was conducted.On (b)(6) there was no redness or swelling of the left upper arm, no scleroma, and the needle was recovered.The patient was discharged from hospital.

Manufacturer Narrative

The device used in treatment has not been returned for evaluation, without this we are unable to complete an analysis to establish a relationship between device and the failure reported.However, this is understandable as the dressing will have been discarded, no photos of the event have been provided to review.A review of the device history has not been possible as no batch/lot number has been provided on this occasion, however please be assured, the manufacturing processes have been reviewed with no events reported that could has caused or contributed to the event reported, with no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Complaint history for the reported event has been reviewed, revealing this as the only complaint recorded with regards to infection.Clinical investigation reports that the loosened dressing may have contributed to the reported infection, but this could not be isolated as the only factor.Infection is a known potential complication of invasive lines and/or procedures with increased risks in the presence of an already compromised immune system.The reported thrombosis is most likely related to the invasive line in the presence of infection and not related to the external/topical dressing.The patient impact beyond the reported signs/symptoms, clinical findings and antibiotic/anti-thrombolytic therapy could not be determined; however, the patient was reportedly discharged without redness or swelling.No further medical assessment could be rendered at this time.A risk management review has taken place in relation to this complaint, the event reported is captured within the file.Local and systemic infections as harms related to dressing lifting or falling off without new dressing being applied.The instructions for use display adequate warnings and cautions, the ifu states, do not stack dressings or allow dressings to overlap.Periodically monitor the dressing and catheter site to confirm secure attachment and continued proper infusion, especially after bathing, showering, or if the dressing and catheter site becomes wet.If the dressing comes off, evaluate to ensure proper catheter placement, and then apply a new dressing.As with all adhesive products, apply and remove carefully from sensitive or fragile skin.The investigation into the reported complaint is now complete and recorded insufficient information to determine a root cause, with no further actions deemed necessary at this time.The investigation has reported findings to assist with the prevention of re-occurrence of this type of event as detailed in the clinical investigation, risk management review and the instructions for use.In parallel we will continue to monitor for any adverse trends relating to this product range.Please be assured that all products are released to market following rigorous quality checks during production and prior to despatch.By acknowledging and investigating your complaint this collaboration enables us to drive our passion to continuously review, improve and steer our shared purpose of providing the best possible outcome for customer and patients.Smith and nephew take all customer complaints and concerns seriously, we strive to have the best understanding of our patients needs and have built a strong culture of care, collaboration and courage to offer a service which we are proud of.

• 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: 9399095
• MDR Text Key: 168780653
• Report Number: 8043484-2019-00879
• 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
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 4008
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 55 YR