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

Catalog Number 326510

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2018

Event Type  malfunction  

Manufacturer Narrative

One unused peripheral intravenous catheter was received for analysis.This was not the same product used in the complaint, however this unused sample was from the same lot number.This sample was tested based on the complaint issue.The take off force, or the initial force that separates the tip of the catheter from the needle, as well as the force to advance, the force required to advance the device tab until locking, were both tested.The resulting values were within specification.Without evaluating the actual sample, it cannot be assessed or confirmed whether a quality related issue has resulted in the user's reported difficulties.The device history record was reviewed and no manufacturing or testing issues were found.Based on the evidence, the complaint was confirmed.

Event Description

Information was received indicating that this peripheral intravenous catheter was dragging upon threading the needle.The difficult insertion caused veins to blow and required additional pokes.No adverse patient effects were reported.

• 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: 7579589
• MDR Text Key: 110456479
• Report Number: 3012307300-2018-02078
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 15019517078411
• UDI-Public: 15019517078411
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 01/16/2020
• Device Catalogue Number: 326510
• Device Lot Number: 3529456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1