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

Catalog Number 4033-AI

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 10/13/2023

Event Type  Injury  

Manufacturer Narrative

Other, other text: investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that following the attempt to establish a peripheral venous line on the right foot of a premature baby in neonatology, a piece of cathlon (foreign body of approximately 1.5cm) remained stuck under the skin after cracking during removal.The reported problem occurred during use on the patient.The operator of the device was a nurse.The incident caused clinical consequences for the patient.The customer indicated that there were associated examinations, and intervention to remove the foreign body was carried out by an orthopedic surgeon.The incident was resolved.

• Brand Name: JELCO PIVC
• 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
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 18107141
• MDR Text Key: 327865030
• Report Number: 3012307300-2023-10425
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K990236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 4033-AI
• Device Lot Number: 4392854
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/09/2023
• Supplement Dates Manufacturer Received: 01/25/2024
• Supplement Dates FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention