Q2 EXTENSION SET, 17 INCH
Received Oct 21, 2015 · Event occurred Sep 4, 2015
Report 1649914-2015-00089 · MDR key 5163528
Device
Generic name
Intravascular Administration Set
Manufacturer
Quest Medical, Inc.Model number
95902Lot number
0492575E05
Product problems
- Disconnection
- Occlusion Within Device
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE HISTORY RECORD FOR THE LOT WAS REVIEWED AND NO DEVICES WERE REJECTED AND NO SPECIFIC MANUFACTURING YIELD ISSUES WERE REPORTED SIMILAR TO THE REPORTED COMPLAINT CONDITION.
Additional Manufacturer Narrative
QUEST MEDICAL, INC. HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC. DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem
REFERENCE MANUFACTURER REPORT NUMBERS: 1649914-2015-00087, 00088, 00090, 00091, AND 00092.