MAUDE Adverse Event Report: CARDINAL HEALTH UMBILICAL CATHETER SINGLE LUMEN 5FR; CATHETER, UMBILICAL ARTERY

Model Number	8888160341
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the umbilical catheter was inserted and then was noted to not have any measurement markings on.It was already inserted when the team realized this.No patient injury reported.
Additional Manufacturer Narrative
According to the dhr review, parameters documented, and quality tests performed for the reported lot number, the lot was manufactured according to standards.There were no discrepancies that could be related to the event reported.The lot was released according to product requirements.Additionally, it was determined that there were no ncrs related to this lot number.The actual sample was not returned for evaluation.No additional information, pictures or videos were received.Consequently, it was not possible to evaluate the affected device as part of a comprehensive failure investigation.It is important to note that there are controls in place to prevent the reported issue from occurring including personnel training, incoming quality acceptance testing for the raw material, in-process material, and finished goods that are based on acceptance criteria.In addition, there is a station on the manufacturing line that verifies the correct positioning of the depth marks and a system that has visual aids for units placement.Based on the available information, a root cause could not be determined.No actions are required at this time.If the sample is returned in the future, the investigation will be reopened for further investigation.This complaint will be used for tracking and trending purposes.

• Brand Name: UMBILICAL CATHETER SINGLE LUMEN 5FR
• Common Device Name: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; edificio b20 calle #2 zona fra; alajuela ; CS
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 15809155
• Report Number: 3009211636-2022-00802
• Device Sequence Number: 17481407
• Product Code: FOS
• UDI-Device Identifier: 20884527005120
• UDI-Public: 20884527005120
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2022

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
• Device Model Number: 8888160341
• Device Catalogue Number: 8888160341
• Device Lot Number: 1822000169
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2022
• Supplement Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 11/16/2022
• Supplement Report FDA Received Date: 12/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown