SPINAL ANESTHESIA KIT ASA-24103-SB

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 2020-02-05 for SPINAL ANESTHESIA KIT ASA-24103-SB manufactured by Arrow International Inc..

Event Text Entries

[177798691] (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


[177798692] It was reported that the lidocaine vial was broken in the kit.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1036844-2020-00042
MDR Report Key9671229
Report SourceHEALTH PROFESSIONAL
Date Received2020-02-05
Date of Report2020-01-31
Date of Event2019-07-02
Date Mfgr Received2020-03-20
Device Manufacturer Date2019-03-06
Date Added to Maude2020-02-05
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 ContactJASMINE BROWN
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9193614124
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 ANESTHESIA KIT
Generic NameNEEDLE, CONDUCTION, ANESTHETIC
Product CodeBSP
Date Received2020-02-05
Catalog NumberASA-24103-SB
Lot Number23F19B0107
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerARROW INTERNATIONAL INC.
Manufacturer AddressREADING PA


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-05

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