MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO VIAVALVE SAFETY IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC

Model Number	308000
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was returned along with no pictures for investigation.A dhr review was conducted and found no anomalies for the related defect.
Event or Problem Description
It was reported that the iv catheter sheared off or missing.Attempted to flush iv saline lock with ns 10ml.Upon flushing iv was not patent and leaking so removed iv and noticed there was no long clear catheter piece, it had broken off completely at the hub of the catheter.Unknown how long it had been like that.The iv was started new yesterday by another community paramedic with no complications.The pt.Had been know to pick and pull at her ivs over the referral.It was a 22g iv.
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.No problems or issues were identified during this device history record review.
Additional Manufacturer Narrative
Corrected b1, corrected data: corrected b1: product problem.

• Brand Name: JELCO VIAVALVE SAFETY IV CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer (Section G): NULL; 201 west queen st.; southington CT 06489
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12929046
• Report Number: 3012307300-2021-12210
• Device Sequence Number: 5615428
• Product Code: FOZ
• UDI-Device Identifier: 10351688071330
• UDI-Public: 10351688071330
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K012128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2023

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 Model Number: 308000
• Device Catalogue Number: 308000
• Device Lot Number: 3972927
• 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: 11/09/2021
• Supplement Date Received by Manufacturer: 03/02/2023; 06/13/2023
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 04/13/2023; 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown