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

Model Number 66024008

Device Problem Defective Component (2292)

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

Event Date 02/10/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference number: (b)(4).

Event Description

It was reported that the patient was admitted to the hospital for hemiplegia and sequelae of cerebral infarction.On february 10, the nurse used the dressing to fix the catheter for picc and when the protective layer of the dressing was removed, it was found that the film layer was wrinkled and could not fix the catheter, and a new piece of the same batch number was opened, and this phenomenon happened again, then the third one was ok.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 into the reported complaint.The batch record was reviewed and it could be confirmed that the products had progressed through a satisfactory release process which involved testing the product against the requirements of the finished product specification.There was also no issue identified during the manufacturing process that could have caused or contributed to the complaint problem.A complaint history review, was performed for the product and event description, there have been similar instances reported in the past three years.Event occurred during patient treatment.The device intended for use in treatment was not returned for evaluation, therefore no functional evaluation could not be carried out, however comprehensive photographs were provided which did establish a relationship between the reported complaint and the device.It has not been possible however to establish the root cause of the issue.The investigation has been closed.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 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
• 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: 11492790
• MDR Text Key: 240029580
• Report Number: 8043484-2021-00602
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223417406
• UDI-Public: 05000223417406
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

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 Model Number: 66024008
• Device Catalogue Number: 4008
• Device Lot Number: 1933
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 03/16/2021
• Supplement Dates Manufacturer Received: 08/06/2021
• Supplement Dates FDA Received: 08/06/2021
• 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 Age: 76 YR