POWER PICC SOLO*2 CATHETER WITH SHERLOCK 3CG* TPS STYLET KIT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-16 for POWER PICC SOLO*2 CATHETER WITH SHERLOCK 3CG* TPS STYLET KIT manufactured by C.r. Bard, Inc..

Event Text Entries

[4836644] Difficulty activating scalpel from picc kit. Device button seemed to stick. Trying to force it open when my hand slipped, the device opened, and the scalpel poked into my skin under my 5th finger on the palm of my right hand. The poke happened prior to the device having contact with the patient's skin who (b)(6). Injury site cleaned and dressed. No harm to patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number4095181
MDR Report Key4095181
Date Received2014-09-16
Date of Report2014-09-16
Date of Event2014-07-11
Report Date2014-09-16
Date Reported to FDA2014-09-16
Date Reported to Mfgr2014-09-17
Date Added to Maude2014-09-17
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePOWER PICC SOLO*2 CATHETER WITH SHERLOCK 3CG* TPS STYLET KIT
Generic NameKIT, CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER TH
Product CodeGDX
Date Received2014-09-16
Model Number*
Catalog Number*
Lot NumberREYD1845
ID Number*
OperatorNURSE
Device AvailabilityY
Device Age1 DA
Device Sequence No1
Device Event Key0
ManufacturerC.R. BARD, INC.
Manufacturer Address730 CENTRAL AVE. MURRAY HILL NJ 07974 US 07974


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2014-09-16

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