0.9% SODIUM CHLORIDE INJECTION, USP, 1000 ML 2B1324

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-17 for 0.9% SODIUM CHLORIDE INJECTION, USP, 1000 ML 2B1324 manufactured by Baxter Healthcare Corporation.

Event Text Entries

[186303140] Flush line was leaking. There have been 4 leaking bags from the respiratory department supply in the last week.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9844455
MDR Report Key9844455
Date Received2020-03-17
Date of Report2020-03-11
Date of Event2020-03-05
Report Date2020-03-11
Date Reported to FDA2020-03-11
Date Reported to Mfgr2020-03-17
Date Added to Maude2020-03-17
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 OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name0.9% SODIUM CHLORIDE INJECTION, USP, 1000 ML
Generic NameCONTAINER, I.V.
Product CodeKPE
Date Received2020-03-17
Model Number2B1324
Lot NumberY328781
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE CORPORATION
Manufacturer AddressUS


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-17

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