CAREFUSION NDC-57613-007-25 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-03-15 for CAREFUSION NDC-57613-007-25 * manufactured by Carefusion.

Event Text Entries

[2409749] A surgeon opened a new package of surgical hand scrub and discovered what he thought was a "bug" stuck on the bristles. The product was sequestered and not used. The manufacturer notified and they will send a mailer to return product for analysis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2495962
MDR Report Key2495962
Date Received2012-03-15
Date of Report2012-03-15
Date of Event2012-03-15
Report Date2012-03-15
Date Reported to FDA2012-03-15
Date Added to Maude2012-03-20
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameCAREFUSION
Generic NameSURGICAL HAND SCRUB
Product CodeGEC
Date Received2012-03-15
Model NumberNDC-57613-007-25
Catalog Number*
Lot Number0000402093
ID Number*
OperatorPHYSICIAN
Device AvailabilityY
Device Age1 DY
Device Sequence No1
Device Event Key0
ManufacturerCAREFUSION
Manufacturer Address3750 TORREY VIEW COURT SAN DIEGO CA 92130 US 92130


Patients

Patient NumberTreatmentOutcomeDate
10 2012-03-15

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