Q2 T CONNECTOR EXTENSION SET W/ Q2 T-SITE-CHECKVALVE, MICROBORE TUB
Received Nov 8, 2017 · Event occurred Aug 15, 2017
Report 1649914-2017-00072 · MDR key 7011813
Device
Generic name
Fluid Delivery Extension Set
Manufacturer
Quest Medical, Inc.Model number
95701Catalog number
95701
Lot number
0531267M05
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED. THE INVENTORY ON THE DEVICE LOT IS DEPLETED AND AN INVESTIGATION COULD NOT BE CARRIED OUT ON A DEVICE FROM THE SAME LOT. A DHR REVIEW WAS CONDUCTED AND THERE WERE NO NON-CONFORMITIES OR DEVIATIONS ASSOCIATED WITH THE MANUFACTURING OF THIS DEVICE. THE REVIEW SHOWED NO ANOMALIES. A COMPLAINT HISTORY REVIEW FOR THE LAST 24 MONTHS WAS ALSO CONDUCTED AND NO SIMILAR ISSUES WERE FOUND. THE ROOT CAUSE OF THE REPORTED ISSUE IS UNKNOWN.
Description of Event or Problem
THE PRODUCT DISTRIBUTOR REPORTED AN ISSUE ENCOUNTERED BY THEIR CUSTOMER WHEN USING THE FLUID DELIVERY EXTENSION SET. THE REPORT STATED THAT A PIECE OF THE DEVICE BROKE OFF DURING DELIVERY OF ANESTHESIA TO A PATIENT DURING A CATARACT PROCEDURE. THEY REPORTED THAT THE FURTHEST PORT, THE ONE AT THE 180 DEGREE ANGLE, IS THE ONE THAT COMPLETELY DISCONNECTED FROM THE REST OF THE TUBING AND THAT THE EXTENSION THAT SITS AT A 90 DEGREE ANGLE TO THE MAIN TUBING WAS INTACT. THEY REPORTED THE BREAK WAS VERY CLEAN WITH N APPARENT MISHANDLING OR SEVERE DAMAGE TO THE UNIT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE DEVICE WAS DISCARDED BY THE CUSTOMER AND NOT RETURNED FOR EVALUATION.