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

Catalog Number IV3000

Device Problem Device Slipped (1584)

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

Event Date 04/01/2013

Event Type  malfunction  

Event Description

Literature case: in a scientific publication: "clinical observation of needle-free closed joint for central venous catheter infusion in neurosurgery".It was reported that 246 patients were using iv3000 (smith&nephew) for fixation and had problems due to infusion set slippage.There is no information regarding to the outcome of the patients or the treatment provided for this complication.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

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.A clinical evaluation was carried out.It was concluded; ¿information obtained from a literature review publication, "clinical observation of needle-free closed joint for central venous catheter infusion in neurosurgery" indicates a patient was using iv3000 for fixation and had problems due to infusion set slippage.There is no information regarding to the outcome of the patient or the treatment provided for this complication.There is no identifying patient information or supporting relevant clinical documentation provided.Therefore, a clinical assessment is unable to be performed at this time.¿ 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
• 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: 10204689
• MDR Text Key: 197161916
• Report Number: 8043484-2020-01100
• 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: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IV3000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 06/28/2020
• Supplement Dates Manufacturer Received: 09/22/2020
• Supplement Dates FDA Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1