MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000 1 HAND 10X12CM CTN 50; TAPE AND BANDAGE, ADHESIVE

Catalog Number 4008

Device Problem Microbial Contamination of Device (2303)

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

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that when the nurse changed the iv3000 dressing of deep venous catheter for the patient, he opened a new dressing and found a white plaque of 1 * 2cm in the dressing, which was similar to mold.It is unknown how the procedure was completed or if there was a delay.No patient harm reported.

Manufacturer Narrative

We have now concluded our investigation for the complaint received.A review of the batch manufacturing records could not be performed as the lot number provided is not a recognised lot number for this product, however, there are no indications to suggest that the device did not meet specifications upon release into distribution.The complaint history file contains no further instances/ related events of the reported event.The device was intended for use in treatment.No samples were returned for analysis.No events during the manufacturing process were identified which may cause or contribute to the reported issue.The reported issue may be caused by device handling / storage passed the point of smith and nephew control.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.

• Brand Name: IV3000 1 HAND 10X12CM CTN 50
• 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: 10968104
• MDR Text Key: 220204782
• Report Number: 8043484-2020-04089
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

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: 4008
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 01/06/2021
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR