MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. DIALYSIS UNKNOWN; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number DIALYSIS UNKNOWN

Device Problem Product Quality Problem (1506)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Title: transjugular tunnelled dialysis catheter tip placement into the inferior vena cava upper segment after length overestimation source j vasc access, volume 16, 2015 (72-75) article number: 1 date of publication: 2 september 2014.(b)(4).

Event Description

According to the literature source of study performed involved a patient undergoing hemodialysis for three months via an intra-jugular tunneled dialysis catheter (ij-tdc) from a different manufacturer (1st device) inserted as a result of persistent staphylococcal exit site infection from a previous peritoneal dialysis (pd) catheter.Two (2) days later, the 1st ij-tdc device experienced poor flow and was then exchanged/replaced with another catheter (2nd device).The patient was subsequently dialyzed uneventfully for 5 months with a blood flow >250 ml/min until he presented with severe sepsis due to staphylococcal catheter-related infection (cri).The 2nd catheter was then removed immediately, and he was dialyzed via a temporary femoral catheter to resolve the issue.

• Brand Name: DIALYSIS UNKNOWN
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer Contact: lisa hernandez ; 15 hampshire street; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 8537871
• MDR Text Key: 142731870
• Report Number: 3009211636-2019-00099
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIALYSIS UNKNOWN
• Device Catalogue Number: DIALYSIS UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2018
• Initial Date FDA Received: 04/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 64 YR