MAUDE Adverse Event Report: ICU MEDICAL, INC CLAVE CONNECTOR; CONNECTOR PORT (MALE)

Model Number 11956

Device Problem Sticking (1597)

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

Event Date 10/04/2016

Event Type  malfunction  

Event Description

Nurses report that several of the needleless connectors, clave the internal septums are sticking when you insert a syringe in the connector to draw blood or flush the line.There have been 10 of these reports but i have only one device saved.

• Brand Name: CLAVE CONNECTOR
• Type of Device: CONNECTOR PORT (MALE)
• Manufacturer (Section D): ICU MEDICAL, INC; 4455 atherton dr.; salt lake city UT 84123
• MDR Report Key: 6046879
• MDR Text Key: 58082442
• Report Number: 6046879
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 04/30/2021
• Device Model Number: 11956
• Device Catalogue Number: 11956
• Device Lot Number: 64-267-HE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/13/2016
• Device Age: 1 DY
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BLOOD DRAWING; NO OTHER THERAPIES