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

Model Number	326510
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was placed in the patient and the tip of the needle broke off in the catheter.The nurse removed the syringe and the tip of the needle from the iv was on the tip of the syringe.No patient injury was reported.
Additional Manufacturer Narrative
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.Operator of device is unknown.Initial reporter also sent report to fda is unknown.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• 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): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15305161
• Report Number: 3012307300-2022-16420
• Device Sequence Number: 6314333
• Product Code: FOZ
• UDI-Device Identifier: 15019517078411
• UDI-Public: 15019517078411
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K160235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2022

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: 09/11/2022
• Device Model Number: 326510
• Device Catalogue Number: 326510
• Device Lot Number: 4044458
• 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: 07/19/2022
• Initial Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown