FDA.reportPublic FDA data

MAUDE MDR 8267021

MDR report key
8267021
Report number
8267021
Event key
0
Event type
3
Date of event
2018-12-10
Date received
2019-01-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
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
1I.V. START KITI.V. START KITMEDLINE INDUSTRIES, INC.LRS18GBE827* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-220

Event Narratives#

D

Patient 1

MEDLINE IV START KIT CRACKED SHORTLY AFTER PLACEMENT. EXTENSION SET TUBING CRACKED AT THE END OF THE LINE. LOT NUMBER (10) 18GBE827.