MAUDE Adverse Event Report: UNOMEDICAL LTD. UNO NIKO-FIX (100/1000) STER IN; INTRAVASCULAR CATHETER SECUREMENT

Model Number 417118

Device Problems Delivered as Unsterile Product (1421); Device Disinfection Or Sterilization Issue (2909)

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

Event Date 06/01/2014

Event Type  malfunction  

Event Description

It is reported that product batches were shipped directly to the distribution centre and shipped to customers but have no record of the sterilization certification.Additional information was received on 10/31/2014 and reported it is undetermined if any product ahs been used or is in use.

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.There were no reports of the patient being harmed as a result of this malfunction.Additional information was requested, but no additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.This complaint involves eight different lots; therefore additional records have been created in order to capture this information and separate fda form 3500a's has been generated to address the other cases.Reported to fda on november 20, 2014.

• Brand Name: UNO NIKO-FIX (100/1000) STER IN
• Type of Device: INTRAVASCULAR CATHETER SECUREMENT
• Manufacturer (Section D): UNOMEDICAL LTD.; zavodskaya street 50; fanipol; dzerzhinsk district minsk region 2227 50; BO 222750
• Manufacturer Contact: matthew walenciak, inter assoc di ; 211 american ave; greensboro, NC 27409-0000
• MDR Report Key: 4317443
• MDR Text Key: 5214040
• Report Number: 3007966929-2014-00094
• Device Sequence Number: 1
• Product Code: KMK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2017
• Device Model Number: 417118
• Device Lot Number: 159427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1