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

Catalog Number 4007

Device Problem Unintended Movement (3026)

Patient Problem Injury (2348)

Event Date 08/04/2020

Event Type  Injury  

Event Description

It was reported that it was found that the crimping of transparent dressing caused the indwelling needle to come out slightly.Finally the indwelling needle was removed.No backup was available.No patient harm reported.

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.The complaint history file contains no further instances/ related events of the reported event.The device was used for treatment.No samples were returned for analysis.A clinical investigation concluded; ¿the causal relationship between the smith and nephew device and the reported crimping of the transparent dressing issue cannot be confirmed.Per complaint, the indwelling iv3000 needle was removed.There was no reported harm to the patient; however, a backup device was not available.It is unknown how the procedure was completed or if there was a delay.Therefore, no further clinical/medical assessment is warranted at this time.¿ the reported issue may be linked to application or maintenance techniques.The instructions for use provides comprehensive instructions of the operation, use and limitations of the device.The associated risk file contains the reported event.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: IV3000 1 HAND 6X7CM CTN 100
• 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: 10557417
• MDR Text Key: 207688442
• Report Number: 8043484-2020-02910
• 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: 02/23/2021

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: 4007
• Device Lot Number: 1834
• Initial Date Manufacturer Received: 08/25/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 02/18/2021
• Supplement Dates FDA Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention