MAUDE Adverse Event Report: MEDCOMP CENTRAL VENOUS CATHETER; CVC

Device Problem Detachment Of Device Component (1104)

Patient Problems Death (1802); Exsanguination (1841)

Event Date 10/16/2017

Event Type  Death  

Event Description

Venous line connection cap separated from patient's cvs during dialysis treatment.Separation of cvc end cap resulted in blood loss greater than 500 mls.Medcomp cvc - (b)(6) 2017.(b)(4).

• Brand Name: CENTRAL VENOUS CATHETER
• Type of Device: CVC
• Manufacturer (Section D): MEDCOMP
• MDR Report Key: 6993141
• MDR Text Key: 90779442
• Report Number: MW5073057
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 54 YR
• Patient Weight: 66