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

Model Number	326310
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4) , as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history record review.One used catheter assembly, without needle guard assembly, sheath component and blister packaging, was returned for analysis.Examination of the catheter assembly and severed catheter tube displayed evidence of catheter severance above the catheter hub nose with no actuator-to-tube tears or catheter bevel tip irregularities noted.Magnified examination of the catheter tube at the point of severance is straight and smooth.The distal end of the tube / point of detachment is straight and smooth.Examination of the sample against the technical report for investigation into causes of catheter tube separation failure modes suggest the catheter tube was inadvertently cut during device removal with a sharp object (scissors).The root cause was due to user error/technique.No correction or corrective actions will be conducted by the manufacturing facility at this time.Complaint information will continue to be monitored.
Event or Problem Description
It was reported that upon initiation into vein blood was leaking out of site, iv removed and flushed and noted leaking from the middle of cannula.No patient injury was reported.

• Brand Name: JELCO VIAVALVE SAFETY I.V. CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16876275
• Report Number: 3012307300-2023-05149
• Device Sequence Number: 12578227
• Product Code: FOZ
• UDI-Device Identifier: 15019517078404
• UDI-Public: 15019517078404
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K160235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/05/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/06/2023
• Device Model Number: 326310
• Device Catalogue Number: 326310
• Device Lot Number: 4166043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2021
• 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