CHLORAPREP SEPP * 260449NSB

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-07-20 for CHLORAPREP SEPP * 260449NSB manufactured by Cardinal Health.

Event Text Entries

[1101741] The rn was preparing to start an iv. The nurse opened the iv start kit and discovered that the chlora prep sepp applicator was empty. The iv start kit and the chlora prep packaging was intact, as was the applicator--but no liquid was inside it. The rn opened another kit and had the same findings: intact applicator but no liquid inside it. A third kit was opened, and staff found that the applicator did have fluid inside. Staff did not save the device or the packaging, although they did note the lot numbers and device information from both the kits and the applicators. Both kits that were faulty came from the same lot numbers as did both applicators. The remaining stock on the unit was checked, but no other problematic devices were found. The remaining kits on the unit are all from the same lot numbers as the ones reported here. The kits are stored in their own bin inside a temperature & humidity controlled room and are not exposed to heat or cold extremes. No condensation was seen in any of the kits affected or on the shelf in the storage room. Manufacturer response (as per reporter) for iv start skin disinfectant, chloraprep seppa copy of this report has been faxed to medline and to cardinal health.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1422059
MDR Report Key1422059
Date Received2009-07-20
Date of Report2009-07-20
Date of Event2009-07-18
Report Date2009-07-20
Date Reported to FDA2009-07-20
Date Added to Maude2009-07-28
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 NameCHLORAPREP SEPP
Generic NameAPPLICATOR, SKIN DISINFECTANT
Product CodeKOY
Date Received2009-07-20
Model Number*
Catalog Number260449NSB
Lot Number26379
ID Number*
Device AvailabilityN
Device Age1 DY
Device Sequence No1
Device Event Key0
ManufacturerCARDINAL HEALTH
Manufacturer Address11400 TOMAHAWK CREEK PKWY SUIT LEAWOOD KS 66211 US 66211


Patients

Patient NumberTreatmentOutcomeDate
10 2009-07-20

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