ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
Received Nov 8, 2017 · Event occurred Oct 20, 2014
Report 1820334-2017-03845 · MDR key 7008991
Device
Manufacturer
Cook IncProduct problems
- Leak/Splash
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: COMMON DEVICE NAME IS "GBO." DUE TO A TECHNICAL ISSUE, THIS INFORMATION COULD NOT BE SAVED IN THE PROPER FIELD, SO IT IS BEING RECORDED HERE. D4- RPN- ULT12.0-38-25-P-5S-CLDM-TONG-050399. THIS MDR IS BEING FILED AFTER THE ASSOCIATED COMPLAINT WAS REVIEWED UNDER REMEDIATION PROTOCOL CAP008, COMPLAINT/MDR RETROSPECTIVE REVIEW AND REMEDIATION AND REASSESSED AS REPORTABLE. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED.
Description of Event or Problem
IT WAS REPORTED THAT PRIOR TO PATIENT CONTACT, LEAKAGE OCCURRED FROM THE CATHETER'S HUB AREA, A NEW PRODUCT WAS USED. THERE WAS NO OF INJURIES.