MAUDE Adverse Event Report: ICU MEDICAL, INC. TD TORQUE-LINE CATHETER

Model Number 41237-06

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2014

Event Type  malfunction  

Event Description

Complaint rec'd reporting unspecified breakage/damage with one 41237-06 td torque-line catheter, 8f, 5 lumen, heparin coated.The initial info reports at unspecified time after the operating room procedure attending clinician was checking ".Cardiac pt.Upon removal (catheter) appear sheared off.There was no apparent injury".The catheter was pre-tested/prior to placement, inserted, or procedure completed with no issues noted.Add'l pt/event info has been requested as of the date of this report there have been no responses.

Manufacturer Narrative

Device return: one (1) used 41237-06 td torque-line catheter, 8f, 5 lumen, heparin coated, unk mfg/list/size contamination shield attached.Visual analysis of the "as-rec'd" used 41237-06 td catheter identified multiple and extensive damages/tears to the catheter device components, thus confirming the report that the device has damaged.Findings: visual assessment of the "as-rec'd" used 41237-06 catheter device recorded extensive damages.The extant and type of damages were due to external influences, excessive force and not as a result of the mfg processes.

• Brand Name: TD TORQUE-LINE CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): ICU MEDICAL, INC.; salt lake city UT 84123
• Manufacturer Contact: terry scesny ; 4455 atherton dr; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 4621120
• MDR Text Key: 18660613
• Report Number: 2025816-2014-00220
• Device Sequence Number: 1
• Product Code: DYG
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 41237-06
• Device Catalogue Number: 41237-06
• Other Device ID Number: PR# 27758
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/17/2014
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/30/2014
• Event Location: Hospital
• Date Manufacturer Received: 10/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNK CONTAMINATION SHIELD