UNKNOWN PERITONEAL CATHETER
Received Nov 22, 2017 · Event occurred Oct 18, 2017
Report 3009211636-2017-05360 · MDR key 7053576
Device
Generic name
Catheter, Peritoneal
Manufacturer
Covidien Mfg Solutions S.a.Model number
UNK PDCatalog number
UNK PD
Lot number
UNKNOWN
Product problems
- Break
- Fluid/Blood Leak
- Break
- Fluid/Blood Leak
Patient
Not reported
- Unspecified Infection
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
THE SITE HAS INDICATED THAT THE INCIDENT SAMPLE HAS BEEN DISCARDED. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
IT IS REPORTED BY BAXTER THAT A CUSTOMER FOUND A RUPTURE IN THE CATHETER NEAR THE TITANIUM JOINT WHICH WAS CAUSING LEAKS AND ABDOMINAL PAIN TO THE PATIENT. THE RUPTURED CATHETER TUBE LEAD TO AN INFECTION. THE PATIENT WAS TREATED IN THE HOSPITAL, THE TUBE HAS BEEN REMOVED AND DIALYSIS WAS DISCONTINUED.