MAUDE Adverse Event Report: CENTURION; IV START KIT

Catalog Number	DYNDV2214B
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that on (b)(6) 2024 the syringe was "cracked" leading to "leaking" while "attempting to flush the j-loop".The customer reported there was no impact to the patient and a new syringe was utilized.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.Due to the reported problem/issue, and 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.
Event or Problem Description
It was reported that on (b)(6) 2024 the syringe was "cracked" leading to "leaking" while "attempting to flush the j-loop".

• Common Device Name: IV START KIT
• Manufacturer (Section D): CENTURION; tri-state de mexico; s. de r.l. de c.v.; mexicali, baja california 21397 ; MX 21397
• Manufacturer Contact: danielle tognocchi ; three lakes dr; northfield, IL 60093-2753
• MDR Report Key: 19067812
• Report Number: 3004519921-2024-00017
• Device Sequence Number: 6695722
• Product Code: LRS
• UDI-Device Identifier: 00653160367027
• UDI-Public: 00653160367027
• 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): 04/08/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYNDV2214B
• Device Lot Number: 2023111590
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 04/08/2024
• 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 Sex: Unknown