MAUDE Adverse Event Report: ICU MEDICAL, INC JELCO VIAVALVE SAFETY IV CATHETER; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	982512D
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: unknown; no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.The device has not been returned to the manufacturer.
Event or Problem Description
It was reported when connecting the holder to the needless connector the male luer broke off.The needless connector was attached to a hickman catheter.The hickman catheter was capped with needleless connectors.The blood collection device was attached to the hickman and the tubes then attached to the collector device.They used just the holder and luer it to the needleless connector then utilizes vacuum tubes to obtain samples.The device broke off into the patient was the luer connector that screws on/into the port of the hickman was broke into the catheter and could not be removed.The event occurred while in use with patient.
Additional Manufacturer Narrative
No product was returned; however, a photo of the device was provided for analysis.The photo was reviewed, and the reported issue was confirmed.The root cause cannot be determined, as no sample was returned for investigation.A review of the device history record (dhr) showed that all inspections were completed, with no issues noted during manufacturing.

• Brand Name: JELCO VIAVALVE SAFETY IV CATHETER
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): ICU MEDICAL, INC; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22556609
• Report Number: 3012307300-2025-08638
• Device Sequence Number: 9637948
• Product Code: FMI
• UDI-Device Identifier: 20351688081794
• UDI-Public: (01)20351688081794(17)300205(10)6089844
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K895705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025

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 Catalogue Number: 982512D
• Device Lot Number: 6089844
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2025
• 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