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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Unspecified Infection (1930); Irritation (1941)

Event Date 10/03/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that after use of a jelco® i.V.Catheter, the patient experienced irritations of the vein, veinitis, and edema on the arm.The patient was undergoing treatment for an e.Coli infection at the time of the event.To address the irritation, veinitis, and edema, the e.Coli antibiotics were stopped, and the medical team provided "local cares" in accordance to service protocol.No permanent injury was reported, and the incident was "closed".

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® I.V. 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: 7080390
• MDR Text Key: 93641266
• Report Number: 3012307300-2017-02509
• 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,health professional,u
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/02/2018

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: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/07/2017
• Initial Date FDA Received: 12/04/2017
• Supplement Dates Manufacturer Received: 12/14/2017
• Supplement Dates FDA Received: 01/02/2018
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ROCEPHINE
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR