MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO PERIPHERAL INTRAVENOUS CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L

Model Number 305306

Device Problems Difficult to Insert (1316); Deformation Due to Compressive Stress (2889)

Patient Problem Abrasion (1689)

Event Date 12/30/2019

Event Type  malfunction  

Event Description

It was reported that it is not easy to penetrate the skin and plastic part kinked outside the skin and always rupture the veins.No patient injury was reported.

Manufacturer Narrative

No lot number was provided; therefore, device history record review could not be completed.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.

• Brand Name: JELCO PERIPHERAL INTRAVENOUS CATHETERS
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15292382
• MDR Text Key: 305251318
• Report Number: 3012307300-2022-16155
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10351688071156
• UDI-Public: 10351688071156
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K990236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 08/25/2022

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 Model Number: 305306
• Device Catalogue Number: 305306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/23/2022
• Initial Date FDA Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1