MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. JELCO

Model Number 4033-AI

Device Problem Dull, Blunt (2407)

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

Event Date 07/22/2021

Event Type  malfunction  

Event Description

Information a smiths medical peripheral intravenous catheters (pivc)|jelco conventional jelco iv catheters reported clinician was unable to access vein.The reported complaint stated patient admitted to pediatric resuscitation service for poor general condition following second degree burns on the body, and urgently needed a jelco24.Due to the complexity of the diagnosis several venipunctures were performed meaning it was necessary to use 7 catheters.They reported to be poor quality ,which is why it is difficult to use.No further information.

• Brand Name: JELCO
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; 1500 eureka park; ashford, kent TN25 4BF; UK TN25 4BF
• MDR Report Key: 12389093
• MDR Text Key: 270489997
• Report Number: 3012307300-2021-08974
• 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: foreign,user facility
• Type of Report: Initial
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4033-AI
• Device Lot Number: 3993860
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 5 YR