MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number 306301

Device Problems Entrapment of Device (1212); Difficult to Insert (1316); Blocked Connection (2888); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 10/08/2021

Event Type  malfunction  

Event Description

After insertion of 24 g iv catheter, there was an inability to place an extension tube into catheter.Upon removing catheter from patient it was noticed that there was a piece of iv mechanism left in the catheter.

• Brand Name: JELCO
• 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 Key: 12790219
• MDR Text Key: 280675850
• Report Number: 12790219
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10351688071224
• UDI-Public: (01)10351688071224
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 306301
• Device Lot Number: 4154437
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31390 DA