PUDENDAL BLOCK TRAY 4541

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-20 for PUDENDAL BLOCK TRAY 4541 manufactured by Carefusion 2200, Inc..

Event Text Entries

[77939608]
Patient Sequence No: 1, Text Type: N, H10


[77939609] Pudendal syringe (blue attachment) pistol drop was not attached properly to the syringe. This led to the needle moving every time aspiration was attempted trying to make sure there wasn't an intravascular placement of needle. The top piece of the pistol grip is missing. It was not in the packaging.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6653064
MDR Report Key6653064
Date Received2017-06-20
Date of Report2017-06-12
Date of Event2017-06-03
Report Date2017-06-07
Date Reported to FDA2017-06-07
Date Reported to Mfgr2017-06-07
Date Added to Maude2017-06-20
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePUDENDAL BLOCK TRAY
Generic NameSET, ANESTHESIA, PARACERVICAL
Product CodeHEE
Date Received2017-06-20
Model Number4541
Catalog Number4541
Lot Number0000800489
OperatorPHYSICIAN
Device AvailabilityY
Device Age0 YR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCAREFUSION 2200, INC.
Manufacturer Address400 EAST FOSTER RD. MANNFORD OK 74044 US 74044


Patients

Patient NumberTreatmentOutcomeDate
10 2017-06-20

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