MAUDE Adverse Event Report: CONVATEC LIMITED EASI-V SECUREMENT DEVICE; INTRAVASCULAR CATHETER SECUREMENT

Model Number 417109

Device Problem Loss of or Failure to Bond (1068)

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

Event Date 02/05/2015

Event Type  malfunction  

Event Description

It was reported the adhesive border of the securement device detaches from the patient's skin within the first two days of use.No patient consequences were reported as a result of this event.

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.Additional patient/event details have been requested.Should additional information become available, a follow-up report will be submitted.Reported to the fda on (b)(4) 2015.

Manufacturer Narrative

Add'l info was received on 06/22/2015.There was no sample received to conduct a root cause analysis.Batch records have been reviewed; all required specs have been met and documented within the batch records.There were no discrepancies noted in the batch record related to the reported complaint issue.This complaint will be closed without further action.After a detailed batch review, no discrepancies were found.There is not enough info to conclude the product did not meet spec and perform as intended.Product monitoring reviews will monitor for product trends if this issue were to reoccur.No further actions are required.No add'l pt/event details have been provided to date.Should add'l info become available a f/u report will be submitted.Reported to fda on july 1, 2015.

• Brand Name: EASI-V SECUREMENT DEVICE
• Type of Device: INTRAVASCULAR CATHETER SECUREMENT
• Manufacturer (Section D): CONVATEC LIMITED; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer Contact: matthew walenciak,interim assoc d ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4834393
• MDR Text Key: 5905699
• Report Number: 1000317571-2015-00058
• Device Sequence Number: 1
• Product Code: KMK
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/02/2015

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 Expiration Date: 11/01/2015
• Device Model Number: 417109
• Device Lot Number: 3L02095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2015
• Initial Date FDA Received: 06/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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