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

Catalog Number	3265103
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Infiltration into Tissue (1931)
Date of Event	05/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation could not be performed given that the actual complaint product sample was not provided by the complainant.The root cause could not be defined with confidence.All materials in the manufacturing process, as well as all finished good products are released to market based on approved quality specification.The lot documentation review reveal that all required testing was performed and the product met acceptance requirement.
Event or Problem Description
It was reported that the nurses were complaining of a drag when threading the catheter forward.They alleged that this either caused the veins to blow, or required having to poke the patient again.No death or serious injury was reported in connection with this incident.

• Brand Name: JELCO SAFETY VIAVALVE 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: 7570847
• Report Number: 3012307300-2018-02065
• Device Sequence Number: 13948061
• Product Code: FOZ
• UDI-Device Identifier: 15019517078411
• UDI-Public: 15019517078411
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 06/05/2018

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: 01/16/2020
• Device Catalogue Number: 3265103
• Device Lot Number: 3529456
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1