UNKNOWN PERITONEAL CATHETER
Received Nov 22, 2017 · Event occurred Oct 30, 2017
Report 3009211636-2017-05359 · MDR key 7053371
Device
Generic name
Catheter, Peritoneal
Manufacturer
Covidien Mfg Solutions S.a.Model number
UNK PDCatalog number
UNK PD
Product problems
- Break
- Break
Patient
62 YR
- Unspecified Infection
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR 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
ACCORDING TO THE REPORTER, DURING USE, THE PERITONEAL DIALYSIS (PD) CATHETER TUBE RUPTURED NEAR THE STOMACH. THE CATHETER HAD BEEN IMPLANTED AND THE PATIENT CHANGES THE GAUZE HERSELF. THE PATIENT HAD LEFT THE GAUZE ON TOO LONG CAUSING THE TUBE TO RUPTURE WHICH LEAD TO AN INTRA-ABDOMINAL INFECTION IN THE PATIENT. THE PATIENT WAS TREATED IN THE HOSPITAL IN (B)(6) AND HAS STOPPED DIALYSIS.