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

Catalog Number 326310

Device Problem Fail-Safe Design Failure (1222)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that when the needle of a jelco® viavalve® safety iv catheter was inserted and hub removed, blood started.No report of patient injury.

Manufacturer Narrative

One used peripheral intravenous catheter was returned for analysis with a locked out needle guard sub-assembly.The catheter sub-assembly was not included so the valve could not be evaluated.The sample had blood residue in the flash chamber, nose and guard.Blood present in the guard is indicative that the deployment chassis was left attached to the catheter hub for a longer than necessary time.The beveled acam which houses the seal was not returned for evaluation.T 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.Based on these observations and the lack of a beveled catheter assembly to examine, the complaint cannot 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; 201 west queen street; southington CT 06489
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7492553
• MDR Text Key: 107566203
• Report Number: 3012307300-2018-01275
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 15019517078404
• UDI-Public: 15019517078404
• 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,Followup
• Report Date: 06/14/2018

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: 07/06/2019
• Device Catalogue Number: 326310
• Device Lot Number: 3423953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/20/2018
• Initial Date FDA Received: 05/07/2018
• Supplement Dates Manufacturer Received: 05/17/2018
• Supplement Dates FDA Received: 06/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2017
• 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