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

Model Number DIALYSIS UNKNOWN

Device Problems Infusion or Flow Problem (2964); Material Twisted/Bent (2981)

Patient Problem No Information (3190)

Event Date 12/01/2018

Event Type  malfunction  

Manufacturer Narrative

Title the inescapable tunneled cuffed dialysis catheters.A single center experience over one year source department of nephrology, volume 28, 2018 (175-176) article number: 112 date of publication: dec 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed for a duration of one year, a total of 161 patients with chronic kidney disease underwent permcath insertion.A total of 135 patients had the site of permcath insertion in the right internal jugular vein, 22 patients in the left internal jugular vein and 13 patients in the left femoral vein.There were three catheter designs used: staggered tip, split tip and over-the-guidewire.There was one catheter with a split-tip design that developed a kink at the catheter tip.There was one misplaced catheter tip requiring subsequent removal.Flow problems also occurred in 45.18% of the patients.

• 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 st.; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 9505088
• MDR Text Key: 196248715
• Report Number: 3009211636-2019-00279
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• 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: 12/09/2019
• 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 Age: 41 YR