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

Catalog Number UNKN05003901

Device Problems Loss of or Failure to Bond (1068); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/10/2014

Event Type  malfunction  

Event Description

On the literature article named "a pilot trial of bordered polyurethane dressings, tissue adhesive and sutureless devices compared with standard polyurethane dressings for securing short-term arterial catheters." the authors of the study reported that, during arterial catheter treatment with iv3000 dressing and veni-grad (conmed).1 patient from the bpu group had adhesive residue during the removal of the dressing.It is unknown if the residue was from the iv3000 dressing or the competitor's dressing.Additional details are unknown.Patient outcome is unknown.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: on the literature article named "a pilot trial of bordered polyurethane dressings, tissue adhesive and sutureless devices compared with standard polyurethane dressings for securing short-term arterial catheters.", the authors of the study reported that, during arterial catheter treatment with iv3000 dressing and veni-grad (conmed), 1 patient from the bpu group had adhesive residue during the removal of the dressing.It is unknown if the residue was from the iv3000 dressing or the competitor's dressing.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 revealed a similar instance in the last three years.The risk files, mitigate the reported issues with no updates required.A clinical review concluded that without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.Probable root cause is incorrect skin preparation, incorrect application or removal of dressings or infrequent dressing changes.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 skin preparation prior to use, application and removal of dressings and recommended frequency of dressing changes.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.

Manufacturer Narrative

On the literature article named "a pilot trial of bordered polyurethane dressings, tissue adhesive and sutureless devices compared with standard polyurethane dressings for securing short-term arterial catheters.", the authors of the study reported that, during arterial catheter treatment with iv3000 dressing and veni-grad (conmed), 1 patient from the bpu group had adhesive residue during the removal of the dressing.It is unknown if the residue was from the iv3000 dressing or the competitor's dressing.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 revealed a similar instance in the last three years.The risk files, mitigate the reported issues with no updates required.A clinical review concluded that without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.Probable root cause is incorrect skin preparation, incorrect application or removal of dressings or infrequent dressing changes.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 skin preparation prior to use, application and removal of dressings and recommended frequency of dressing changes.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: 13062620
• MDR Text Key: 284834298
• Report Number: 8043484-2021-02045
• 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,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN05003901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/14/2022
• 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