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

Model Number 1303698

Device Problems Failure to Disinfect (1175); 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 has been used or is in use.

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.There were no reports of the patient being harmed as a result of this malfunction.No additional patient/event details have been provided to date.A return sample for evaluation has not been received however a quality evaluation is in progress.Should additional information become available, a follow-up report will be submitted.This complaint involves twelve different lots; therefore additional records have been created in order to capture this information and separate fda form 3500's has been generated to address the other cases.(b)(4).

• Brand Name: UNO NIKO-FIX (100/1000) STER IN
• Type of Device: INTRAVASCULAR CATHETER SECUREMENT
• Manufacturer (Section D): CONVATEC LIMITED; first avenue; deeside industrial park; deeside, flintshire CH5 2NU; UK CH5 2NU
• Manufacturer Contact: matthew walenciak, int assoc dir ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4239293
• MDR Text Key: 22267164
• Report Number: 1000317571-2014-00103
• 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: 11/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2017
• Device Model Number: 1303698
• Device Lot Number: 170784
• 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
• 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