ALL-IN-ONE CONTAINER ARB8124P

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-21 for ALL-IN-ONE CONTAINER ARB8124P manufactured by Baxter Healthcare Corporation.

Event Text Entries

[175753354] Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[175753355] It was reported that the all-in-one container was leaking from the port. This was identified during an unspecified patient infusion. There was no patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1416980-2019-07639
MDR Report Key9612902
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-01-21
Date of Report2020-02-26
Date of Event2019-12-24
Date Mfgr Received2020-02-21
Device Manufacturer Date2019-09-30
Date Added to Maude2020-01-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPHARMACIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street25212 W. ILLINOIS ROUTE 120
Manufacturer CityROUND LAKE IL 60073
Manufacturer CountryUS
Manufacturer Postal60073
Manufacturer Phone2242702068
Manufacturer G1BAXTER HEALTHCARE - CALI
Manufacturer StreetCALLE 36 NO. 2C-22 APARTADO AERO 2446
Manufacturer CityCALI
Manufacturer CountryCO
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameALL-IN-ONE CONTAINER
Generic NameCONTAINER, I.V.
Product CodeKPE
Date Received2020-01-21
Returned To Mfg2020-01-14
Model NumberNA
Catalog NumberARB8124P
Lot NumberSE19IL4
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE CORPORATION
Manufacturer AddressDEERFIELD IL


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-21

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