MAUDE Adverse Event Report: CENTURION; TRIPLE LUMEN CVC KIT - 20CM

Catalog Number	ECVC5400
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, after placing a central venous catheter device a "ct scan" showed retained guidewire fragments.The customer reported there was "nothing abnormal" noted regarding the product prior to the ct scan and the line was able to be "aspirated and flushed" without difficulty.The customer reported as a result of the reported incident the patient required retrieval of the fragments with an interventional radiology procedure.The customer reported the patient was also prescribed antibiotic therapy and home health care upon discharge.Sample requested for return evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer, after placing a central venous catheter device a "ct scan" showed retained guidewire fragments.

• Common Device Name: TRIPLE LUMEN CVC KIT - 20CM
• 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 drive; northfield, IL 60093
• MDR Report Key: 18016359
• Report Number: 3004519921-2023-00016
• Device Sequence Number: 7593445
• Product Code: LRO
• UDI-Device Identifier: 10653160365891
• UDI-Public: 10653160365891
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/26/2023

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: ECVC5400
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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