MAUDE Adverse Event Report: JELCO; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM

Catalog Number 7134-INT

Device Problems Fracture (1260); Physical Resistance/Sticking (4012)

Patient Problem Swelling/ Edema (4577)

Event Date 04/24/2020

Event Type  malfunction  

Event Description

Information was received indicating that the nurse had difficulty introducing a smiths medical peripheral intravenous catheters (pivc)| jelco safety intuitiv catheter.Once in the vein, the nurse felt a resistance by moving up the catheter.When withdrawing the needle, a swelling of the vein was observed.It was also reported that by withdrawing the cathlon, fracture was observed.Edema was observed on the patient.No further adverse effects were reported.

• Brand Name: JELCO
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• MDR Report Key: 12474867
• MDR Text Key: 271489304
• Report Number: 3012307300-2021-09369
• 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: 09/15/2021

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: No Information
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 7134-INT
• Device Lot Number: 2969698
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/07/2021
• Initial Date FDA Received: 09/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1