MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO® IV CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number H

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Edema (1820); Sepsis (2067)

Event Date 10/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that after use of a jelco® iv catheter, the patient experienced irritation and sepsis in the veins.It was noted that actions taken at the hospital included "hand wash procedure, follow of the set up of catheters".No permanent injury was reported.

Event Description

It was then reported that the patient had edema on his arm at the irritation.The patient received 3 days of antibiotics (rocephine flagyle) and was stopped when blood culture was negative.

Manufacturer Narrative

No sample was returned for evaluation.A review of the sterilization records was performed and found that all parameters comply with the specified requirements.A review of the device history record was performed and did not show anomalies related to the reported issue.Based on the evidence, a root cause was unable to be confirmed.

• Brand Name: JELCO® IV CATHETER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ITALIA S.R.L.; via della stazione, 2; 04010 latina scalo; latina, ; IT
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7041187
• MDR Text Key: 92332081
• Report Number: 3012307300-2017-02446
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2022
• Device Model Number: H
• Device Catalogue Number: 4030-AI
• Device Lot Number: 3460098
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR