MAUDE Adverse Event Report: MEDCOMP ASH TUNNELER; TUNNELED CATHETER

Model Number 8490800449

Device Problems Fracture (1260); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 07/21/2015

Event Type  malfunction  

Event Description

An ash tunneler sleeve fractured when being loaded for use.Did not reach the pt.Vendor was contacted and identified a defective part that was changed.The fractured tunneler was taken by the vendor for return to the mfr for eval.

• Brand Name: MEDCOMP ASH TUNNELER
• Type of Device: TUNNELED CATHETER
• MDR Report Key: 4964745
• MDR Text Key: 6635718
• Report Number: MW5045036
• Device Sequence Number: 1
• Product Code: MSD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8490800449
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 61