MAUDE Adverse Event Report: ICU MEDICAL, INC. TD CATHETER 8F, 5 LUMEN, 110CM, HEPARIN COATED

Model Number 41232-02

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2015

Event Type  malfunction  

Event Description

Complaint received stating, "the balloon that was inflated in the pt on our swan ganz central line - ruptured - while trying to deflate.This was retracted without incident.We placed a new one and worked fine." no pt adverse consequences reported.

Manufacturer Narrative

Lot #41-589-sj was manufactured in june of 2014 for (b)(4) each.The lot was manufactured, tested, inspected and released with no anomalies.No product returned for investigation.

• Brand Name: TD CATHETER 8F, 5 LUMEN, 110CM, HEPARIN COATED
• Type of Device: TD CATHETER
• Manufacturer (Section D): ICU MEDICAL, INC.; salt lake city UT 84123
• Manufacturer Contact: robert gillispie ; 4455 atherton dr; salt lake city, UT 84123 ; 8012641702
• MDR Report Key: 4768541
• MDR Text Key: 5949627
• Report Number: 2025816-2015-00048
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/14/2015

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 Expiration Date: 06/01/2015
• Device Model Number: 41232-02
• Device Catalogue Number: 41232-02
• Device Lot Number: 41-589-SJ
• Other Device ID Number: PR# 29902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2015
• Initial Date FDA Received: 05/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• Patient Sequence Number: 1