MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO; INTRAVASCULAR CATHETER

Model Number	308000
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was returned along with no pictures for investigation.A dhr review was conducted and found no anomalies for the related defect.
Event or Problem Description
It was reported that the iv catheter sheared off or missing.Attempted to flush iv saline lock with ns 10ml.Upon flushing iv was not patent and leaking so removed iv and noticed there was no long clear catheter piece, it had broken off completely at the hub of the catheter.Unknown how long it had been like that.The iv was started new yesterday by another community paramedic with no complications.The pt.Had been know to pick and pull at her ivs over the referral.It was a 22g iv.

• Brand Name: JELCO
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12920565
• Report Number: 3012307300-2021-12146
• Device Sequence Number: 12010558
• Product Code: FOZ
• UDI-Device Identifier: 10351688071330
• UDI-Public: 10351688071330
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/02/2021

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?: No
• Device Model Number: 308000
• Device Lot Number: 3972927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown