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; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
  • 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; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION Back to Search Results
Model Number 96000
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/26/2023
Type of Reportable Event Malfunction
Event or Problem Description
Elderly male in ed (emergency department) with sudden onset of confusion and visual impairment.Procedure: iv infusion- iv adapter stuck in the hub of saf-t holder device.The adapter broke while trying to remove the loop.Another adapter and loop used without difficulty.No known harm to patient, delay in care.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
JELCO
Common Device Name
TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan ln n
minneapolis MN 55442
MDR Report Key18083301
Report Number18083301
Device Sequence Number7730466
Product Code JKA
UDI-Device Identifier20351688062953
UDI-Public(01)20351688062953(17)20280403(10)4389385
Combination Product (Y/N)N
Initial Reporter StateOH
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type User Facility
Initial Reporter Occupation Risk Manager
Type of Report Initial
Report Date (Section B) 10/30/2023
Report Date (Section F) 10/30/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number96000
Device Lot Number4389385
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location Hospital
Date Report to Manufacturer11/07/2023
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date11/07/2023
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Unknown
Patient Sequence Number1
Patient SexMale
Patient Weight107 KG
Date Report Sent to FDA10/30/2023
-
-