MAUDE Adverse Event Report: UNOMEDICAL LTD. NIKO-FIX; DEVICE, INTRAVASCULAR CATHETER SECUR

Model Number 417118

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

Patient Problem Sepsis (2067)

Event Date 11/01/2014

Event Type  Injury  

Event Description

It was reported unsterile niko-fix securement (s) were used on a number of immunosuppressed patients in the hematology/oncology ward that developed sepsis.The health care professional could not provide an exact number of patients affected nor attribute a specific lot number.The potentially involved reported lot numbers that were provided are: 159427, 159428, 159439, 162484, and 170512.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.Additional information was requested on 12/08/2014 and received on 12/10/2014 confirming the product material model number and informing that no additional information could be obtained on any other patients, lots and or events.No further information is available at this time.Should additional information become available, a follow-up report will be submitted.

• Brand Name: NIKO-FIX
• Type of Device: DEVICE, INTRAVASCULAR CATHETER SECUR
• Manufacturer (Section D): UNOMEDICAL LTD.; zavodskaya street 50; fanipol dzerzhinsk district, minsk region; minskaya voblasts 0000 2227; BO 000022275
• Manufacturer Contact: matthew walenciak, assoc director ; 211 american avenue; greensboro, NC 27409
• MDR Report Key: 4346407
• MDR Text Key: 5178496
• Report Number: 3007966929-2014-00134
• Device Sequence Number: 1
• Product Code: KMK
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 417118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2014
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening