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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-07 for * manufactured by Medline Industries, Inc..

Event Text Entries

[18918540] During setup for a left heart catheter procedure, part of the pack for set up - the tip of a wire that goes into a catheter - was observed to be broken. It looked disjointed. This had no patient affect due to this being set up prior to the case. Also a new wire was used that was not part of a pack. It was replaced with a. 035 j wire from another vendor (out of catheter lab stock) and it worked just fine.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number4526138
MDR Report Key4526138
Date Received2015-01-07
Date of Report2015-01-07
Report Date2015-01-07
Date Reported to FDA2015-01-07
Date Reported to Mfgr2015-02-19
Date Added to Maude2015-02-19
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand Name*
Generic NameCARDIAC CATHETERIZATION KIT
Product CodeOES
Date Received2015-01-07
Model Number*
Catalog Number*
Lot Number14JB4917
ID Number*
OperatorOTHER
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES, INC.
Manufacturer AddressUNKNOWN ONE EEDLINE PLACE MUNDELEIN IL 60060 US 60060


Patients

Patient NumberTreatmentOutcomeDate
10 2015-01-07

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