MAUDE Adverse Event Report: IVERA MEDICAL CUROS DISINFECTING PORT PROTECTOR; NONE

Model Number 002-250

Device Problem Break (1069)

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

Event Date 07/11/2014

Event Type  malfunction  

Event Description

The curos caps are breaking while patients are moving around in bed and also break apart as the nurse removes the cap.

Manufacturer Narrative

Notification of the mdr was provided through a letter from the fda dated on (b)(4) 2014.The letter was received at ivera on (b)(4) 2014.The reported device was not returned by the user facility nor was the lot number communicated.Without the device or lot number, ivera is not able to investigated the reported issue.Contact was made with the user facility, which they indicated that issues were minor and non-significant.There was no patient of safety related incident and they have not had any additional issues since the recent reports.Ivera did review verification requirements that are conducted in manufacturing of the product.Sampling is conducted on a continuous periodic basis, which tensile verification is part of inspection to confirm that a minimum retention force when engaged with a needleless luer activated valve (lav).Manufacturing limits are established on the manufacturing equipment, which is monitored real-time.If an excursion occurs outside the manufacturing limits, the manufacturing equipment will automatically segregate product produced at the time the excursion occurs.

• Brand Name: CUROS DISINFECTING PORT PROTECTOR
• Type of Device: NONE
• Manufacturer (Section D): IVERA MEDICAL; carlsbad CA
• Manufacturer Contact: neal hartman ; 2731 loker ave west; carlsbad, CA 92010 ; 8583826550
• MDR Report Key: 4197148
• MDR Text Key: 4963019
• Report Number: 3008142801-2014-00001
• Device Sequence Number: 1
• Product Code: LKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/15/2014

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: 002-250
• Device Catalogue Number: 002-250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2014
• Initial Date FDA Received: 09/27/2014
• 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