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 Injury (2348)

Event Date 06/25/2016

Event Type  Injury  

Manufacturer Narrative

A modified de novo insertion technique for catheter replacement in elderly hemodialysis patients: a single clinic retrospective analysis source journal of vascular access, volume 17, 2016 (506-511).Article number: 6 date of publication online: 27 september 2016.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed to asses the effectiveness of a modified de novo insertion technique for replacement or catheter removal (tdc- tunneled cuff catheters).As the technique has not yet been studied comprehensively, retrospective study was performed to evaluate the safety and efficacy of de novo placed catheter without delay for catheter replacement in elderly hemodialysis patients.A retrospective review of 164 elderly patients was conducted during a period (84 patients in study group, as well as 80 patients in a control group) who had catheter replacement by guide wire exchange technique.All catheters were placed successfully.Thirty-two(32) cases of catheter related infections of which 8 are specified as catheter tunnel infections.

• 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 ; CR 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CR 20101
• Manufacturer Contact: lisa hernandez ; 15 hampshire street; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 10335360
• MDR Text Key: 200835898
• Report Number: 3009211636-2020-00158
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• 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
• Date Manufacturer Received: 07/09/2020
• 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): Other
• Patient Age: 70 YR