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

Catalog Number 3260

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that a smiths medical device was hard to thread.It was noted that the device locked up causing the nurse to miss the patient.No injury was reported.

Manufacturer Narrative

One used deployment chassis was received for investigation.Examination of the returned deployment chassis did not reveal any abnormalities.The deployment chassis moved freely and locked normally.No beveled catheter assembly was returned to evaluate the complete device for deployment efficacy and or replication of deployment in a vein pad.

• Brand Name: JELCO® VIAVALVE® SAFETY IV 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 NORTH AMERICA; 201 west queen street; southington CT 06489
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7430902
• MDR Text Key: 105520917
• Report Number: 3012307300-2018-01162
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 15019517078398
• UDI-Public: 15019517078398
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 12/05/2019
• Device Catalogue Number: 3260
• Device Lot Number: 3541906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1