MAUDE Adverse Event Report: MEDCOMP 10F POLY TESIO CATH(RIGHT)KIT; BIO-FLEX TESIO HEMODIALYSIS CATHETER

Model Number BFR-6E.

Device Problem Disconnection (1171)

Patient Problem Blood Loss (2597)

Event Date 03/06/2019

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated.We are currently waiting for additional information regarding the incident and the availability of the device for evaluation.

Event Description

During a dialysis session, the venous bloodline was separated from the venous branch of the catheter.It was reconnected immediately upon noticing the issue.At the level of the catheter venous luer, aire was noted in the tubing and a leak resulting in loss of blood was noted.There was no difficulty during the connection and no issue with the catheter luer.Caregiver states the issue did not result from movement or mobilization of the patient.Patient was given oxygen and placed in a head down position.Patient suffered blood loss of approximately 300 ml.

Manufacturer Narrative

The device involved in the incident was not returned, additional information was requested but not provided.With the limited information provided and without an evaluation of the device, it is not possible to determine the root cause of this issue.The hemodialysis treatment uses the catheter and a blood tubing set manufactured by a different company (nikkiso).Without an evaluation of the device involved it cannot be determined if there is a catheter issue or an issue with the blood tubing set.It is also possible a good connection was not made during the initiation of the treatment.The luer is designed in accordance with and compliance to the iso standard.

• Brand Name: 10F POLY TESIO CATH(RIGHT)KIT
• Type of Device: BIO-FLEX TESIO HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8522258
• MDR Text Key: 142190215
• Report Number: 2518902-2019-00024
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908004830
• UDI-Public: 884908004830
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: BFR-6E.
• Device Catalogue Number: BFR-6E.
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BLOOD TUBING SET-NIKKISO AV18AFB; BLOOD TUBING SET-NIKKISO AV18AFB
• Patient Outcome(s): Required Intervention