MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKN IV3000; TAPE AND BANDAGE, ADHESIVE

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was documented on the paper "the application of nursing model of whole-course education for patients and their families in picc catheterization for chemotherapy patients", that the iv 3000 (smith and nephew) was applied to 73 patients and there were 37 cases with a catheter obstruction.It is unknown if a treatment was performed or if the event was resolved.

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 part or lot numbers were 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 across all iv3000 products, there have been further complaints reported with this failure mode in the past three years.The devices were intended for use in treatment.As no samples were returned a product evaluation could not be carried out.Dressings should be periodically monitored to ensure proper catheter placement.If the dressing becomes wet or the integrity is compromised, catheter placement may be impacted.The clinical evaluation was carried out.It was concluded; ¿the data provided is from a chinese article, ¿the application of nursing model of whole-course education for patients and their families in picc catheterization for chemotherapy patients." the provided translation was presented in excel spreadsheet in english.Related to article under master case-2020-00007868.Per subsequent e-mail it was noted, ¿no additional information is available.¿ without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The root cause of the catheter obstruction and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should additional medical information be provided this complaint will be re-assessed.¿ 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: UNKN IV3000
• 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
• MDR Report Key: 10231204
• MDR Text Key: 197604081
• Report Number: 8043484-2020-01608
• 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: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2020
• Patient Sequence Number: 1