MAUDE Adverse Event Report: 3.5FR DUAL-LUMEN UVC CATH; CATHETER, UMBILICAL ARTERY

Model Number 8888160531

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/13/2021

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

The customer reported that the device was leaking between 11-12 cm.There was no patient harm reported.

Manufacturer Narrative

Since no lot number was available, a manufacturing device history record (dhr) review or product/process changes review for the involved lot number could not be performed.However, all dhrs are reviewed for accuracy prior to product release.One catheter was received for its respective analysis and investigation.According to the test performed visual inspection did not reveal mayor signs of use.During the physical evaluation the sample was submitted to underwater testing and a leak was observed between 11-12 cm of the catheter and an irregular cut was identified that produced the leak.The event reported was confirmed.According to the sample and event description the most probable root cause is related with a customer use because the catheter did not present any leaks prior to use and was implanted in the patient for 3 days before the leak was identified.A corrective and preventive action (capa) is not deemed necessary at this time.It must be noted that in-process controls, such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

Event Description

The customer reported that the device was leaking between 11-12 cm.There was no patient harm reported.Additional information was received and stated that the device was used on the patient from (b)(6) 2021 at 02:27 to (b)(6) 2021 at 05:00.The leaking issue was noticed on (b)(6) 2021 at 04:00.

Manufacturer Narrative

See section b3 for event date information.Section b5 has been updated to include additional information provided by the customer.

• Brand Name: 3.5FR DUAL-LUMEN UVC CATH
• Type of Device: CATHETER, UMBILICAL ARTERY
• MDR Report Key: 12166793
• MDR Text Key: 261491618
• Report Number: 3009211636-2021-00758
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 20884527005175
• UDI-Public: 20884527005175
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8888160531
• Device Catalogue Number: 8888160531
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1