MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS; ULTRASOUND PIV KIT

Catalog Number	DYNDV2580
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Syringe broke with flush attaching to needleless connector.
Additional Manufacturer Narrative
It was reported that the "syringe broke with flush attaching to needleless connector; needleless connector depressed and stuck open, blood poured out of patient" due to this "more than anticipated blood loss for standard piv insertion.Required iv removal and replacement".It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: ULTRASOUND PIV KIT
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS; tri-state de mexico, s. de r.l; mexicali, baja california 21397 ; MX 21397
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 21900233
• Report Number: 3004519921-2025-00010
• Device Sequence Number: 4085231
• Product Code: LRS
• UDI-Device Identifier: 10653160359937
• UDI-Public: 10653160359937
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: DYNDV2580
• Device Lot Number: 2024101690
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 56 KG