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 No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4) title bilateral central vein stenosis: options for dialysis access and renal replacement therapy when all upper extremity access possibilities have been lost source j vasc access, volume 15, 2014(466-473) article number: 6 date of publication: 2 april 2014.If information is provided in the future, a supplemental report will be issued.[pe# (b)(4)].

Event Description

According to literature source of study performed between january 2009 and december 2012, on 146 patients with end-stage renal disease (esrd) to compare patency rates of different access and renal replacement treatment (rrt) modalities in patients with bilateral central vein stenosis/occlusion.One hundred forty-six vascular access modalities were attempted in 62 patients, of which 8 had received pd (peritoneal dialysis) catheter inserted into the peritoneum.It was stated in the study that on the 8 pd group 2 had culture-proven bacteraemia.No patients died as a result of loss of access.There was no reported patient outcome.

• 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: 8537940
• MDR Text Key: 142735614
• Report Number: 3009211636-2019-00101
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 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
• Initial Date Manufacturer Received: 04/11/2019
• 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): Required Intervention