MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. VIAVALVE SAFETY I.V. CATHETER; INTRAVASCULAR, THERAPEUTIC, SHORT-TERM

Model Number	326310
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the safety device of the intravenous (iv) catheter malfunctioned during each iv stick attempted, leaving the needle exposed and the vein blown.No patient injury was reported.
Additional Manufacturer Narrative
Other, other text: no product sample was received; therefore, visual, and functional testing could not be performed.A device history review (dhr) was performed, and found no discrepancies or abnormalities relevant to the complaint.No root cause could be determined as the complaint could not be confirmed.
Additional Manufacturer Narrative
Other, other text: while performing a review of submitted mdr report it was discovered that this file was inadvertently assessed as reportable.No patient death, serious injury, and no evidence of a reportable product malfunction.The hazardous situation for the given complaint device would not likely cause or contribute to a death or serious injury if the malfunction were to recur.Report 3012307300-2022-08750 is no longer considered reportable, please disregard any mdr reports associated with it.

• Brand Name: VIAVALVE SAFETY I.V. CATHETER
• Common Device Name: INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): NULL; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14383408
• Report Number: 3012307300-2022-08750
• Device Sequence Number: 6743528
• Product Code: FOZ
• UDI-Device Identifier: 15019517078404
• UDI-Public: 15019517078404
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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 Expiration Date: 07/04/2021
• Device Model Number: 326310
• Device Catalogue Number: 326310
• Device Lot Number: 3846389
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0352-2020
• Patient Sequence Number: 1
• Patient Age: 1 YR
• Patient Sex: Male