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

Catalog Number 19120-AJ

Device Problems Material Fragmentation (1261); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/31/2019

Event Type  Injury  

Manufacturer Narrative

Foreign: (b)(6).

Event Description

Information was received that a smiths medical jelco plus iv catheter tip was torn off accidentally while in use.Subsequently, the torn piece was removed successfully from the patient.No additional adverse patient effects were reported.

Manufacturer Narrative

Two catheters were returned for evaluation.Visual inspection of one of the devices was found to be in good condition.Visual inspection of the other found the tip of the catheter to be cut three mm from the bevel.Once the cannula is assembled, the units are 100% tested in order to demonstrate that the catheter tube is properly secured to the hub.The reported complaint has been confirmed, and the cause of the issue has been determined to a result of user interface.The failure has been identified to be a result of improper use of the device.This investigation revealed no intrinsic evidence to suggest a cause of issue related to manufacturing.

• Brand Name: JELCO PLUS IV CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8938041
• MDR Text Key: 155792368
• Report Number: 3012307300-2019-04600
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/04/2024
• Device Catalogue Number: 19120-AJ
• Device Lot Number: 3770842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Date Manufacturer Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention