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

Model Number 002-250

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 08/03/2014

Event Type  malfunction  

Event Description

Curos cap broke apart.Little green ring stayed on the iv port when rn took the cap off.This apparently happened twice.

Manufacturer Narrative

Mdr was observed when conducted a search of fda's maude database on september 25, 2014.No other notification was provided by the user facility nor (b)(4)'s sale representatives.The reported device was not returned by the user facility nor was the lot number communicated.Without the device or lot number, (b)(4) is not able to investigated the reported issue.(b)(4) could not contact the user facility since contact information from the user facility was indicated in the reported information.(b)(4) 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 avenue west; carlsbad, CA 92010 ; 8583826550
• MDR Report Key: 4333601
• MDR Text Key: 5141353
• Report Number: 3008142801-2014-00002
• Device Sequence Number: 1
• Product Code: LKB
• Combination Product (y/n): N
• PMA/PMN Number: K111992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Type of Report: Initial
• Report Date: 08/15/2014

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
• Initial Date Manufacturer Received: 09/24/2014
• 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