| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | Q2 IV EXTENSION SET | IV EXTENSION SETS | QUEST MEDICAL, INC | FPK | 95906 | 054872 | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-07-17 | 0 | 1. R |
Patient 1
THE FACILITY WAS CONTACTED SEVERAL TIMES TO REQUEST FOR INFORMATION ABOUT THE REPORTED INCIDENT AND RESPONSES RECEIVED INDICATE THE FACILITY HAS NO KNOWLEDGE OF THE INCIDENT. NO INFORMATION HAS BEEN PROVIDED BY THE FACILITY TO AID IN THE INVESTIGATION. NO COMPLAINT SAMPLE WAS RETURNED FOR EVALUATION. THE DHR REVIEW DID NOT IDENTIFY ANY ANOMALIES RELATED TO THE REPORTED COMPLAINT CONDITION. A FOLLOW UP MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.
Patient 1
A COPY OF A MEDWATCH WAS RECEIVED BY QUEST MEDICAL ON 6/28/2018. THE MEDWATCH STATES THAT A NURSE WAS FLUSHING THE LINE AND THERE WAS A "SUDDEN RESISTANCE" AT WHICH TIME THE CAP CAME OFF AND FLUID SPRAYED OUT OF THE PIVO CONNECTION PORT INTO HER EYE, FACE AND ARM.
Patient 1
ADDITIONAL INFORMATION RECEIVED DURING AN ON SITE VISIT TO THE USER FACILITY INDICATES THAT THE INCIDENT OCCURRED. THE USER FACILITY STATED THAT DURING THE PROCEDURE, THE NURSE FELT RESISTANCE BUT CONTINUED TO FLUSH THE LINE AT WHICH TIME, THE FLUID SPRAYED THROUGH THE Q2 DEVICE. A SUSPECTED CAUSE OF THE COMPLAINT CONDITION IS AN OCCLUDED IV CATHETER WHERE THE POTENCY OF THE CATHETER MAY NOT HAVE BEING VERIFIED BEFORE INJECTION IN LINE WITH HOSPITAL PROTOCOLS. REVIEW OF THE MANUFACTURING PROCESS DID NOT SHOW ANY PROCESS ANOMALY AT THE TIME OF INVESTIGATION. DURING MANUFACTURING, THE PARTS ARE AQL SAMPLED AND INSPECTED FOR LEAK. ALL THE INSPECTION EQUIPMENT WERE FOUND TO BE CALIBRATED. THE ROOT CAUSE OF THE INCIDENT IS NOT MANUFACTURING RELATED.