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

Model Number 8888160341

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/14/2022

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 307659141
• Report Number: 3009211636-2022-00802
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 20884527005120
• UDI-Public: 20884527005120
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• 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
• Date Manufacturer Received: 11/14/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1