MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS CENTURION; CVC INSERTION BUNDLE

Model Number	ECVC5125
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the information available, no patient injury occurred.This event is being reported based on its similarity to a previous submission.Additionally, it should be noted that although the returned guidewire was broken, the needle was not returned for evaluation.Therefore the cause of the damage was not able to be determined.
Event or Problem Description
Unable to advance guidewire through needle.

• Brand Name: CENTURION
• Common Device Name: CVC INSERTION BUNDLE
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS; 100 centurion way; williamston, mi
• MDR Report Key: 9749921
• Report Number: 1038445-2020-00001
• Device Sequence Number: 727507
• Product Code: OES
• UDI-Device Identifier: 10653160286929
• UDI-Public: (01)10653160286929(10)2019052950(17)200831
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/25/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: ECVC5125
• Device Lot Number: 2019052950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 02/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Weight: 90