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

Catalog Number 5063-AI

Device Problems Difficult To Position (1467); Difficult to Advance (2920); Protective Measures Problem (3015)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 03/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

Information was received indicating that this peripheral intravenous catheter was difficult to use with children and there were concerns with the safety mechanism.It was noted that the catheter had no safe fixation and that it displaced easily.It was also noted that the catheter had no support device in its handling hindering introduction into the vein of a child.The result of this was repetition of the procedure which led to pain and discomfort.No adverse patient effects were reported.

• Brand Name: JELCO® OPTIVA® I.V. CATHETERS
• 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 INTERNATIONAL LTD; 1500, eureka park; lower pemberton; ashford, kent TN25 4BF; UK TN25 4BF
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7516091
• MDR Text Key: 108366842
• Report Number: 3012307300-2018-01558
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2018

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 Expiration Date: 11/16/2022
• Device Catalogue Number: 5063-AI
• Device Lot Number: 3541758
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1