DELTRAN PLUS ABC-350NP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-12 for DELTRAN PLUS ABC-350NP manufactured by Utah Medical Products, Inc..

Event Text Entries

[178958777] Infant with arterial blood transducer in place, but it was not reading a waveform well and had trouble drawing from it. It was found to be clotted off during the night and the line was removed. There was no known harm to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9699914
MDR Report Key9699914
Date Received2020-02-12
Date of Report2019-11-18
Date of Event2019-10-28
Report Date2019-12-31
Date Reported to FDA2019-12-31
Date Reported to Mfgr2020-02-12
Date Added to Maude2020-02-12
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDELTRAN PLUS
Generic NameARTERIAL BLOOD SAMPLING KIT
Product CodeCBT
Date Received2020-02-12
Catalog NumberABC-350NP
Lot Number1191159
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerUTAH MEDICAL PRODUCTS, INC.
Manufacturer Address7043 SOUTH 300 WEST MIDVALE UT 84047 US 84047


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-12

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