FDA.reportPublic FDA data

MAUDE MDR 7792898

MDR report key
7792898
Report number
7792898
Event key
0
Event type
3
Date of event
2018-07-24
Date received
2018-08-17
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MEDICAL ACTION INDUSTRIESI.V. START KITMEDICAL ACTION INDUSTRIES, INC.LRS267014247027* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-08-170

Event Narratives#

D

Patient 1

STERILITY ISSUE: NURSE WAS GETTING READY TO START IV, LOOKED AT IV START KIT PULLED FROM SUPPLY CART, AND HE NOTICED A HAIR THAT IS SEALED IN PACKAGE. IV START KIT WAS NOT OPENED AND TAKEN TO QUALITY OFFICE.