MAUDE Adverse Event Report: ICU MEDICAL, INC. CLAVE CONNECTOR; CLAVE CONENCTOR

Model Number 11956

Device Problems Connection error (1116); Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2014

Event Type  malfunction  

Event Description

Complaint received reporting attachment/leakage concerns with use of 11956 clave connectors and cadd pump tubing and unk mating/access devices.It was reported that ".Outpatient chemotherapy practice recently started using the blue clave with their ambulatory infusion cadd pumps.Have had three instances in approx 2-3 weeks where the clave has come loose resulting in an open iv line, bleeding, and an open line of hazardous medications." there were no reported adverse pt consequences.Additional incident and usage info including status of device/set-up returns has been requested.As of the date of this report there has been no response.Mfrs investigation: the product account manager met with the involved clinicians to observe their usage/techniques with ".Attaching the clave to the cadd pump tubing.It was observed that they were not engaging/mating the components correctly.In-servicing was performed".

Manufacturer Narrative

A two year review of the complaint database for 11956/attachment issues did record additional reports/investigations.A review of those device return investigations identified mixed findings including usage/errors; no defect found; unk.There were no findings that identified/verified a contributing mfg./design related non-conformance.Findings: the involved devices/set-ups were not returned for analysis and verification.Although the exact cause(s) of the reported product experiences/issue are unk, site visit/in-servicing with staff did identify technique/usage conditions most likely contributed to the reported product issues.

• Brand Name: CLAVE CONNECTOR
• Type of Device: CLAVE CONENCTOR
• Manufacturer (Section D): ICU MEDICAL, INC.; salt lake city UT 84123
• Manufacturer Contact: terry scesny ; 4455 atherton drive; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 3821245
• MDR Text Key: 22265789
• Report Number: 2025816-2014-00049
• 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: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11956
• Device Catalogue Number: 11956
• Other Device ID Number: PR# 24447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/01/2014
• Event Location: Home
• Date Manufacturer Received: 03/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CADD PUMP TUBING