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
Medical Device Problem Code	Fail-Safe Design Failure (1222)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL, ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7492553
• Report Number: 3012307300-2018-01275
• Device Sequence Number: 18881012
• Product Code: FOZ
• UDI-Device Identifier: 15019517078404
• UDI-Public: 15019517078404
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K160235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2018
• Supplement Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1