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

Catalog Number 326710

Device Problems Sticking (1597); Difficult to Advance (2920)

Patient Problem Discomfort (2330)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the cathlon of a jelco® viavalve® safety iv catheter was hard to advance.It was observed that the cathlon "was sticking" and that there was a ring on the plastic cathlon.Minor discomfort in the patient was noted.No permanent injury was reported.

Manufacturer Narrative

Three labels and three unused catheter assemblies were returned for evaluation.The completed needle guard assembly was not returned for evaluation and therefore, a complete evaluation was unable to be performed.Based on the evidence, a root cause was unable to be confirmed.

• Brand Name: JELCO® VIAVALVE® SAFETY 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 NORTH AMERICA; 201 west queen street; southington CT 06489
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7121298
• MDR Text Key: 94978695
• Report Number: 3012307300-2017-02609
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 15019517078435
• UDI-Public: 15019517078435
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K160235
• 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
• Report Date: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/09/2019
• Device Catalogue Number: 326710
• Device Lot Number: 3507072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2017
• 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