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

Catalog Number UNKNOWN

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

Patient Problem Insufficient Information (4580)

Event Date 05/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On the literature article named "cerebrospinal fluid infection associated with silver-impregnated external ventricular drain catheters", it was reported that, during treatment of patients that underwent placement of an evd with silver impregnated evd catheter and iv3000 dressing applied to the wound, 52 patients of 263 required the return to the operating room for a replacement of the evd due to unknown reasons.Additional details about how the treatment was concluded are unknown.Patients¿ outcome is unknown.

Manufacturer Narrative

B3: the actual occurrence date is unknown.For the purpose of this report we have used the date the publication of the literature article as the occurrence date.B5: literature citation atkinson r, fikrey l, jones a, pringle c, patel hc.Cerebrospinal fluid infection associated with silver-impregnated external ventricular drain catheters.World neurosurg.2016 may;89:505-9.Doi: 10.1016/j.Wneu.2016.01.034.Epub 2016 jan 22.Pmid: 26805688.H10: additional information the complaint was received as a result of issues being identified in a literature article and according to the article the patients had to revisit the operating room for a replacement of an evd during treatment with the device.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.As no lot number was provided it was not possible to carry out a device history review a complaint history review on the product family revealed a small number of similar instances in the last three years.The instructions for use and risk files, mitigate the reported issue with no updates required.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 prevent 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.D4: corrected catalog number.

Event Description

On the literature article named "cerebrospinal fluid infection associated with silver-impregnated external ventricular drain catheters", it was reported that, during treatment of patients that underwent placement of an evd with silver impregnated evd catheter and iv3000 dressing applied to the wound, 52 patients of 263 required the return to the operating room for a replacement of the evd due to unknown reasons.Additional details about how the treatment was concluded are unknown.Patients¿ outcome is unknown.

• 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: 13078613
• MDR Text Key: 282723173
• Report Number: 8043484-2021-02054
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/28/2022
• 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: A
• Patient Sequence Number: 1