MAUDE MDR 7885010

MDR report key
7885010
Report number
1518293-2018-00033
Event key
0
Event type
3
Date of event
2018-08-20
Date received
2018-09-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
FRED RECKELHOFF
Address
2111 E GALBRAITH ROAD CINCINNATI OH 45237 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1INJ. OPTIV DH, W/OEMINJ. OPTIV DH, W/OEMLIEBEL-FLARSHEIMIZQ844007Y *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-09-180

Event Narratives#

D

Patient 1

INITIAL NOTIFICATION ON (B)(6) 2018, REPORTER STATES THAT INTERMITTENTLY, WHEN PUTTING ON SYRINGES USER CAN NOT SEE IF AIR IS PRESENT, POTENTIAL AIR INJECTION, PATIENT ATTACHED AND FELT ILL AFTER INJECTION. REPORT RECEIVER SPOKE WITH CT TECHNOLOGIST, AND SHE SAID THEY HAVE DIFFICULTY MAKING SURE THAT ALL OF THE AIR IS PURGED OUT OF THE SYRINGE AND Y-TUBING. SHE ASKED IF LF HAS A CLEAR, NON-OPAQUE, SYRINGE AVAILABLE. REPORT RECEIVER EXPLAINED THAT WE DO NOT. SHE WAS NOT ASSERTING THAT THE INJECTOR MALFUNCTIONED AND CAUSED AIR TO BE INJECTED, RATHER SHE SAID THAT THE FACT THAT THE 200 ML SYRINGES ARE OPAQUE AND NOT CLEAR CONTRIBUTED TO A POSSIBLE AIR INJECTION. THEY HAVE DECIDED NOT TO USE THE INJECTOR UNTIL AN FSE COMES AND LOOKS AT THE SYSTEM. THEY WOULD ALSO LIKE APPLICATIONS TO GIVE THEM A CALL. IN REGARDS TO PATIENT INJURY, REPORTER STATES THAT TECH HOOKED UP CONTRAST AND SALINE SYRINGES, HIT AUTO FILL, WENT TO SCANNER, THE INJECTOR SAID IT WAS FILLED. TECH CANNOT SEE IF ITS FILLED. TECH HIT PURGE. LOOKED LIKE CONTRAST CAME IN, SALINE CAME IN. LOOKED AS IF IT WAS WORKING, HOOKED UP TO PATIENT. PATIENT GOT WARM ASSUMED SHE GOT CONTRAST, BUT THEN AIR CAME THROUGH BECAUSE PATIENT GO A LOT OF AIR? PATIENT STARTED COUGHING AND SAID FELT ILL. INJECTOR SAID THERE WAS 100 CC'S IN THERE WAS AIR ON THE SCAN. EVERYTHING SEEMED AS IF IT WAS WORKING OK, BUT TECH STATES CLEARLY WAS NOT. FOLLOW-UP WITH REPORTER ON (B)(6) 2018, REPORTER STATES THAT THE CONTRAST AND SALINE USED DURING THIS PROCEDURE WAS OMNIPAQUE 300 AND AN UNNAMED NON-GUERBET 0.9% SODIUM CHLORIDE.