MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. JELCO CONVENTIONAL JELCO IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L

Catalog Number 4033-AI

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/23/2020

Event Type  Injury  

Event Description

Information was received indicating that upon removal of a smiths medical jelco conventional iv catheter from the patient, it was found difficult to remove.It was reported that a small amount of the catheter was left in the patient's skin.Subsequently, the retained catheter was removed with forceps.The patient recovered and was discharged home.

Manufacturer Narrative

Corrected information: a4 and b3.

• Brand Name: JELCO CONVENTIONAL JELCO IV CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; 1500 eureka park; ashford, kent TN25 4BF; UK TN25 4BF
• MDR Report Key: 10007285
• MDR Text Key: 189305316
• Report Number: 3012307300-2020-03452
• 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,Followup
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 4033-AI
• Device Lot Number: 3816014
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 4