SPINAL ANES/EPIDURAL CATH KIT UI-05502

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-23 for SPINAL ANES/EPIDURAL CATH KIT UI-05502 manufactured by Arrow International Inc..

Event Text Entries

[184649900] (b)(4). The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10


[184649901] It was reported that the glass vial of saline was broken within the kit.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1036844-2020-00095
MDR Report Key9868420
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-23
Date of Report2020-03-09
Date of Event2020-03-09
Date Mfgr Received2020-03-09
Device Manufacturer Date2019-11-21
Date Added to Maude2020-03-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactEFFIE JEFFERSON
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194332672
Manufacturer G1ARROW INTERNATIONAL INC.
Manufacturer Street312 COMMERCE PLACE
Manufacturer CityASHEBORO NC 27203
Manufacturer CountryUS
Manufacturer Postal Code27203
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSPINAL ANES/EPIDURAL CATH KIT
Generic NameANESTHESIA CONDUCTION CATHETER
Product CodeBSO
Date Received2020-03-23
Catalog NumberUI-05502
Lot Number23F19L0282
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerARROW INTERNATIONAL INC.
Manufacturer AddressREADING PA


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.