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

Catalog Number 5063-AI

Device Problems Difficult to Insert (1316); Kinked (1339)

Patient Problem Pain (1994)

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported that the patient was a child.The exact age is unknown.(b)(6).

Event Description

It was reported while attempting to insert a jelco® optiva® i.V.Catheter, the catheter kinked "turning it impossible to insert".The "painful process of puncture" had to be repeated on the same patient.No permanent injury was reported.

• Brand Name: JELCO® OPTIVA® 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: 7052596
• MDR Text Key: 93294425
• Report Number: 3012307300-2017-02459
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: PO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 5063-AI
• Device Lot Number: 3401530
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2017
• 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