Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO 20G X 1 1/4 PROTECT IV PLUS; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITHS MEDICAL ASD, INC. JELCO 20G X 1 1/4 PROTECT IV PLUS; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 306601
Device Problem Retraction Problem (1536)
Patient Problem Pain (1994)
Event Date 08/25/2021
Event Type  malfunction  
Event Description
Unable to retract needle from 20g x 1 1/4 inch iv into plastic safety device during piv placement.Still able to place device for use.Site painful to patient but no injury noted upon placement and obtained blood return for lab draw and flushed line with 10 ml normal saline flush.Large potential for unintentional needle stick of patient or staff.Multiple rns had the same - unable to retract needle issue.Since the packaging was not saved we can not validate for sure which lot number was associated with this issue.We did go ahead and remove from service the lot number, 4165857, we expected to be involved.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
JELCO 20G X 1 1/4 PROTECT IV PLUS
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan ln n
minneapolis MN 55442
MDR Report Key12383685
MDR Text Key268685245
Report Number12383685
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 08/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number306601
Device Catalogue Number306601
Device Lot Number4165857
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/26/2021
Event Location Hospital
Date Report to Manufacturer08/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-