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

Catalog Number 4033-AI

Device Problems Difficult to Insert (1316); Difficult to Advance (2920)

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

Event Type  malfunction  

Event Description

It was reported that the intravenous catheter was difficulty to insert and slide into the vein without snapping it.The difficulty has resorted in several attempts needed to insert the catheter.No patient injury was reported.

Manufacturer Narrative

One unused catheter from the complaint lot number was received to perform an investigation.A visual analysis of the retuned sample did not show any anomalies.The needle was sharp, the bevel and diameter were within specification and the wall thickness and trim length measurements were both within specification.The problem reported was unable to be confirmed.A device history record (dhr) review was performed, and no issues were noted during manufacture.No root cause could be determined as the complaint could not be confirmed.D5 and e4 are unknown.No information has been provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.

• Brand Name: JELCO IV CATHETER, RADIOPAQUE
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT TERM
• 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: 15469957
• MDR Text Key: 305793218
• Report Number: 3012307300-2022-20193
• 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,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 09/22/2022

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 Catalogue Number: 4033-AI
• Device Lot Number: 3989941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1