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

Catalog Number	326310
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
See mfr: 3012307300-2018-00833, 3012307300-2018-00879, 3012307300-2018-00880, 3012307300-2018-00881, 3012307300-2018-00882, 3012307300-2018-00883.
Event or Problem Description
It was reported that the smiths medical device "blood return big veins" and the device was hard to slide.It was indicated that a nurse blew a vein.No other information was provided.
Additional Manufacturer Narrative
One peripheral intravenous catheter was returned for analysis in used condition.Visual inspection of the catheter noted that the sub-assembly was not included so the valve could not be evaluated.The sample had some residue in the flash chamber and trace amounts in the noses as expected from normal use.The nose and cannula were measured to verify that they conformed to specification, as excessive clearance may result in blood leakage through the guard.The cannula and nose were within specification.Based on the evidence, the complaint was unable to be confirmed.

• Brand Name: JELCO® VIAVALVE® SAFETY IV CATHETERS
• 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: 7381763
• Report Number: 3012307300-2018-00883
• Device Sequence Number: 13701366
• Product Code: FOZ
• UDI-Device Identifier: 15019517078404
• UDI-Public: 15019517078404
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K160235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2018

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: Nurse
• Device Expiration Date: 07/08/2019
• Device Catalogue Number: 326310
• Device Lot Number: 3423954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2018
• Supplement Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 06/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1