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

Catalog Number UNKN05003901

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

Patient Problem Bacterial Infection (1735)

Event Date 12/01/2017

Event Type  Injury  

Event Description

On the literature article named "haemodialysis central venous catheter exit site dressings in the tropics: a crossover randomised controlled trial", the authors of the study reported that, when using iv3000 dressing to hold a haemodialysis central venous catheter, 4 patients suffered from a laboratory-confirmed catheter-related infection.The causative microorganisms were staphylococcus aureus (exit site), achromobacter xylosoxidans (exit site), staphylococcus aureus (exit and tip), klebsilla pneumoniae (blood culture) and aeromonas hydrophilia (present in tip of cvc).The outcome of the patients was not reported.

Manufacturer Narrative

Internal complaint reference case (b)(4).

Manufacturer Narrative

Section h3, h6: as no lot number was provided it was not possible to carry out a device history review a documentation review has been conducted, confirming previous complaints of this nature.The instructions for use and risk files, mitigate the reported issue with no updates required.The device was used for treatment and was not returned for analysis.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.It was reported that the patient experienced an infection.A clinical assessment determined that without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The users of the reported product are advised to consult the ifu, to delineate future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device, including application and removal of dressings and skin preparation prior to use.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.

• 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
• 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: 13078567
• MDR Text Key: 282721199
• Report Number: 8043484-2021-02053
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/21/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKN05003901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/02/2021
• Initial Date FDA Received: 12/23/2021
• Supplement Dates Manufacturer Received: 01/21/2022
• Supplement Dates FDA Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other