MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-03-25 for manufactured by Na.

Event Text Entries

[21707366] A 50 year old pt presented for a small bowel exam. It was reported that the pt was mistakenly injected with liquid e-z-paque (barium sulfate suspension) through a groshong catheter which was positioned in the right atrium of the heart (approximately 40 cc's of barium was injected). It was stated that there was a misunderstanding between the pt and the technician in that the pt insisted that this was how the procedure was to be performed. The technician mistakenly took the pt's word for it and proceeded to inject the barium. After completion of the procedure, the pt expressed that she felt sick and had to vomit. However, the pt never vomited. The pt was transferred to intensive care sometime afterward. The chief technican at the facility contacted e-z-em, inc. For medical consultation regarding the ramifications of this and what could be done for the pt. E-z-em's vice president for imaging products contacted one of co's consulting physicians and then relayed to the chief technician that a chest film of the pt should be performed to identify the location of the barium bolus and that they should consult with a pulmonologist and neurologist in the unlikely event that the barium should get beyond the pulmonary barrier. The chief technologist expressed that she would relay this info to the radiologist and that she would contact co if they had any further questions. Follow up with the chief technologist on 1/15 revealed that the pt was doing okay and was released from intensive care. It was also stated that the barium had not gotten to the chest and is currently concentrated in the liver and spleen. On 3/3 e-z-em's medical director spoke to the hospitals director of risk management with respect to a 60 day follow up on the pt's progress. It was indicated that the pt was doing very well from the standpoint of the barium sulphate mis-administration but was a continual visitor to the hosp due to her underlying disease.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2411512-1998-00001
MDR Report Key184184
Report Source05,06
Date Received1998-03-25
Date of Report1998-01-05
Date of Event1998-01-05
Date Facility Aware1998-01-05
Report Date1998-01-05
Date Reported to Mfgr1998-01-05
Date Mfgr Received1998-01-05
Date Added to Maude1998-08-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNA
Generic NameNA
Product CodeKTA
Date Received1998-03-25
Model NumberNA
Catalog NumberNA
Lot NumberNA
ID NumberNA
OperatorNOT APPLICABLE
Device Availability*
Device AgeNA
Device Eval'ed by Mfgr*
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key179055
ManufacturerNA
Manufacturer AddressNA NA *


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 1998-03-25

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