MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number	96000
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly female with history of recent external fixation of right lower extremity.Procedure: lab draw from iv hub.Female adaptor broke while using to draw labs.Plastic piece stayed stuck in patient¿s iv hub, removed without harm to patient.

• Brand Name: JELCO
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 19049623
• Report Number: 19049623
• Device Sequence Number: 8471863
• Product Code: JKA
• UDI-Device Identifier: 20351688062953
• UDI-Public: (01)20351688062953(17)4452095(10)20290110
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/15/2024
• Report Date (Section F): 03/15/2024

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 Number: 96000
• Device Lot Number: 20290110
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/05/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Sex: Female
• Date Report Sent to FDA: 03/15/2024