MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. JELCO CONVENTIONAL JELCO IV CATHETERS; INTRAVASCULAR CATHETER

Catalog Number 4033-AI

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2020

Event Type  Injury  

Manufacturer Narrative

No device was returned for investigation.

Event Description

It was reported that no return in window.Multiple punctures were needed, the veins were damaged.

• Brand Name: JELCO CONVENTIONAL JELCO IV CATHETERS
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; 1500 eureka park; ashford, kent TN25 4BF; UK TN25 4BF
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; 1500 eureka park; ashford, kent TN25 4BF; UK TN25 4BF
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13360347
• MDR Text Key: 284516519
• Report Number: 3012307300-2022-01795
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 4033-AI
• Device Lot Number: 3855261
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2021
• Initial Date FDA Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 4 MO