MAXPLUS * MP1000-C

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-15 for MAXPLUS * MP1000-C manufactured by Carefusion 303, Inc..

Event Text Entries

[3544244] The port was cracked. Air is able to enter the line and cause bubbles. What was the original intended procedure? Iv connection. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3164275
MDR Report Key3164275
Date Received2013-05-15
Date of Report2013-05-07
Date of Event2013-05-06
Report Date2013-05-07
Date Reported to FDA2013-05-15
Date Reported to Mfgr2013-06-12
Date Added to Maude2013-06-12
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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 Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameMAXPLUS
Generic NameCONNECTOR, TUBING, IV
Product CodeOJA
Date Received2013-05-15
Returned To Mfg2013-05-10
Model Number*
Catalog NumberMP1000-C
Lot Number*
ID Number*
OperatorNURSE
Device AvailabilityR
Device Age1 YR
Device Sequence No1
Device Event Key0
ManufacturerCAREFUSION 303, INC.
Manufacturer Address3750 TORREY VIEW COURT SAN DIEGO CA 92130 US 92130


Patients

Patient NumberTreatmentOutcomeDate
10 2013-05-15

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