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

Catalog Number 326710

Device Problems Leak/Splash (1354); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Information was received indicating that this peripheral intravenous catheter was difficult to thread and exhibited leaking at the valve. No adverse patient effects were reported.

Manufacturer Narrative

One jelco® viavalve® safety iv catheter was returned for analysis. The customer's reported problem was "the ivc was not threading properly and valve leaking. " the catheter sub-assembly was not included; so the valve could not be evaluated. Blood was present in the guard. It would appear that the excessive presence of blood may be a deployment training issue as the deployment chassis would have to be left attached to the catheter hub for a long period of time for the amount of blood to leak. When manually advancing the assembly with slight downward pressure to simulate clinical use, it was observed that advancement was difficult and uneven in feel. However, this may be due to the presence of blood residue. Regarding the leakage, based on these observations and the lack of a beveled acam to examine, it is unconfirmed that the complaint was due to a manufacturing non-conformance. Regarding the threading complaint, based on these observations the presence of it is unconfirmed that the complaint was due to a manufacturing non-conformance. The manufacturing processes were reviewed and considered adequate and correct.

• 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: 7430536
• MDR Text Key: 105459443
• Report Number: 3012307300-2018-01163
• Device Sequence Number: 1
• Product Code: FOZ
• 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,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/14/2018

1 Device was Involved in the Event

0 Patients were 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

• Device Expiration Date: 09/19/2019
• Device Catalogue Number: 326710
• Device Lot Number: 3496130
• 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
• Event Location: No Information
• Date Manufacturer Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2017
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage