CHAIT ACCESS ADAPTER
Received Oct 21, 2016 · Event occurred Sep 21, 2016
Report 1820334-2016-01211 · MDR key 6046300
Product problems
- Leak/Splash
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DEVICE PROCODE: GCD. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.
Description of Event or Problem
IT WAS REPORTED THE CONNECTION TUBE OF THE CHAIT ACCESS ADAPTER WAS LEAKING DURING AN UNKNOWN TYPE OF PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Additional Manufacturer Narrative
INVESTIGATION - EVALUATION: A REVIEW OF THE DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE DEVICE FAILURE ANALYSIS AND PHYSICAL EXAMINATION OF THE DEVICE USED IN THIS CASE COULD NOT BE PERFORMED. A REVIEW OF THE PRODUCTION AND QUALITY DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE COMPLAINT LOT NUMBER WAS NOT PROVIDED. BASED ON THE PROVIDED INFORMATION AND RESULTS OF THE INVESTIGATION A DEFINITIVE ROOT CAUSE COULD NOT BE CONCLUSIVELY BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. MONITORING FOR SIMILAR COMPLAINTS WILL CONTINUE.