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

Catalog Number	328300
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: device has not been returned to date.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that iv cannula is supposed to be blood less.The filter is not working as iv cannulas have been leaking.There was patient involvement, and no harm/adverse event was reported.
Additional Manufacturer Narrative
D9: date returned to mfg.: 6/25/2024.H3 and h6.Evaluation codes: updated.One used device without sheath component and packaging was returned for analysis.The sample was visually examined for potential nonconformances.The needle guard assembly displayed normal flash in the flashback chamber with no blood pooling inside the guard and nose inner diameter noted.There was also no evidence of any cannula outer diameter to nose inner diameter.Gaping noted in the needle guard assembly that could potentially result in leakage.Initial visual examination of the catheter assembly did not reveal any unusual conditions that would cause the complaint.Pressure testing, using a water filled syringe, of the catheter assembly indicated no evidence of leakage in the catheter tube or hub components.The sample was received with the seal component actuated.The seal component was gently removed from the catheter assembly for examination with no visible damage noted in the components¿ inner and outer diameter.Based on device analysis, the complaint cannot be confirmed as a manufacturing related nonconformance, and a root cause is unknown.To avoid blood pooling in the needle guard, the clinician needs to complete the insertion process and lock out the device without hesitation or pausing once the flash-vue window is beyond the valve.It is important to note, as the flash-vue window moves beyond the valve during this process, blood will continue to exit the window until the device is properly locked out.No corrective actions will be conducted by the manufacturing facility at this time.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: JELCO SAFETY VIAVALVE CATHETERS
• 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
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19463841
• Report Number: 3012307300-2024-04525
• Device Sequence Number: 7973480
• Product Code: FOZ
• UDI-Device Identifier: 10351688081971
• UDI-Public: (01)10351688081971(17)251204(10)4451234
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K160235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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: 12/04/2025
• Device Catalogue Number: 328300
• Device Lot Number: 4451234
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2024
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown