Q2 EXTENSION SET, 17 INCH
Received Oct 20, 2015 · Event occurred Sep 2, 2015
Report 1649914-2015-00087 · MDR key 5163476
Device
Generic name
Intravascular Administration Set
Manufacturer
Quest Medical, Inc.Model number
95902Lot number
0492575E05
Product problems
- Occlusion Within Device
Patient
Not reported
- No Consequences Or Impact 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
THE HOSPITAL PHARMACY MANAGER REPORTED ISSUES THAT OCCURRED WITH THE Q2 IV ADMINISTRATION/EXTENSION SET DURING USE. SHE REPORTED THAT SHE WAS AWARE OF SIX RECENT INCIDENCES WHERE THE 0.22 MICRON FILTER ON THE TUBING SET BECAME CLOGGED AND OCCLUDED. THE PATIENT INFORMATION WAS NOT RECORDED IN ANY OF THE INSTANCES. THE INFUSATE WAS RECORDED IN THE LAST OCCURRANCE AS (B)(4). THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENTS. THE HOSPITAL DID NOT SAVE THE SAMPLES TO RETURN TO THE MANUFACTURER FOR EVALUATION BECAUSE THEY TYPICALLY CONTAIN CHEMOTHERAPY DRUGS. REFERENCE MANUFACTURER REPORT NUMBERS: 1649914-2015-00088, -00089, -00090, -00091, -00092.