BLAKEMORE TUBE, 3 LUMEN, 21 FR 36" 21FR 36" 2300-21

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-11-02 for BLAKEMORE TUBE, 3 LUMEN, 21 FR 36" 21FR 36" 2300-21 manufactured by Rusch, Inc..

Event Text Entries

[18145] Device was needed for a critically ill pt in an intensive care unit. The first two tubing sets were taken from the storage area and it was found that the latex balloons had deteriorated in the package. The third set was used on the pt. The third set was in good condition.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1026041
MDR Report Key27783
Date Received1995-11-02
Date Added to Maude1995-11-06
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameBLAKEMORE TUBE, 3 LUMEN, 21 FR 36"
Generic NameBLAKEMORE TUBE
Product CodeFEF
Date Received1995-11-02
Model Number21FR 36"
Catalog Number2300-21
Lot NumberBATCH # E313225
OperatorOTHER
Device Availability*
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key28681
ManufacturerRUSCH, INC.
Manufacturer Address2450 MEADOWBROOK PKWY DULUTH GA 30136 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1995-11-02

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