MAUDE Adverse Event Report: 5.0FR URETHANE UMB CATH; CATHETER, UMBILICAL ARTERY

Model Number 8888160341

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 05/08/2021

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.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

Customer reports: the single lumen umbilical arterial catheter was leaking blood.It was noted that there was a hole in the catheter tubing within the first 2 inches from connection end.

Manufacturer Narrative

A device history record (dhr) review revealed no discrepancies that may have contributed to a complaint of this reported issue.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the visual, physical, and dimensional evaluation results concludes the product met specification requirements.In addition, all dhr were reviewed prior to the product release to confirm all requirements were met.One used catheter from lot number 1923400325 and product code 8888160341 was received inside of its original package opened for analysis and investigation.The visual inspection revealed that the catheter was used due to residues of blood that was identified.The catheter showed an extension that does not belong to the original product.During the physical evaluation the sample was submitted to underwater testing and a leak was identified.The reported event was confirmed.Based on the event description "chlorhexidine 2 and 70% alcohol were used to clean the device before insertion, but it was not used on the catheter tube." according to the instructions for use (ifu) of the product, ¿do not use alcohol, acetone, or alcohol containing antiseptics directly on the catheter.Carefully check antiseptic solutions for alcohol or acetone.These substances may cause irreversible damage to the polyurethane which can lead to a leak or break¿.Therefore, the most probable root cause can be considered as a deviation from the ifu.According to occurrence analysis performed for this complaint the probability calculated of occurrence of harm (p1 x p2) is (o-1) is equal than the probability expected of occurrence of harm (p1 x p2) is (o-1) defined in the risk analysis chart (rac) for the argyle¿ umbilical vessel catheters (uvcs)¿.Therefore, a corrective or preventive action is not deemed necessary.A formal corrective/preventative action (capa) was not required for this issue and according to procedure cardinal health distributed product field action assessment (dpfa) procedure¿ a dpfa was not required for this issue.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 performed at the plant t to prevent non-conforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• Brand Name: 5.0FR URETHANE UMB CATH
• Type of Device: CATHETER, UMBILICAL ARTERY
• MDR Report Key: 11802627
• MDR Text Key: 252361480
• Report Number: 3009211636-2021-00746
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 20884527005120
• UDI-Public: 20884527005120
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8888160341
• Device Catalogue Number: 8888160341
• Device Lot Number: 1923400325
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/08/2021
• 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