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

Model Number 8888160531

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/05/2021

Event Type  Injury  

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

The customer reported while suturing a 3.5 fr uvc catheter, it inadvertently broke at the 8cm mark and was unable to be retrieved.An x-ray was immediately taken and the line fragment was in the inferior vena cava.The patient was transferred via lifeflight to a children's specialty hospital.The baby was taken to interventional radiology where they were able to retrieve the fragment from the left pulmonary artery.

Manufacturer Narrative

A device history review for the lot number 2011900052 was performed and revealed no discrepancies that may have contributed to the reported issue.All quality assurance testing performed during manufacturing were acceptable.The quality assurance review of the visual, physical, and dimensional evaluation results indicated that the product met specification requirements.The results of the tensile test for this lot number were above expected values.Tensile reference specification 2.5lbf.One used catheter product id 8888160531, lot number 2011900052 was received with its original package for evaluation.A visual inspection of the sample revealed that the catheter was broken at 8cm with a clean cut (without stretch marks).The catheter was measured to verify the outside diameter, inside diameter and wall thickness; all dimensions were found within specification.The sample was analyzed to verify the necessary force to break the catheter using a tensile test; the rupture valued achieved was 5.87 lbf above reference tensile force specification.The reported issue was confirmed as the catheter tube was received at the manufacturing site in two parts.However, based on the available information, it can be concluded that the product was manufactured according to specifications.The exact root cause could not be determined.The most probable root cause is that the clean cut was caused by a sharp instrument during use.Controls such as staff training, 100% in-process visual inspection, and visual, dimensional, and functional test sampling by qa during the manufacturing process are in place to prevent non-conforming product from leaving manufacturing operations.At this time, a corrective or preventive action is not deemed necessary.This complaint will be used for tracking and trending purposes.Cardinal health is committed to ensuring customer satisfaction by providing products of only the highest quality.Therefore, your feedback is essential and greatly appreciated.This feedback helps us to identify areas of improvements in our ongoing quality assurance efforts.

• Brand Name: 3.5FR DUAL-LUMEN UVC CATH
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• MDR Report Key: 11657025
• MDR Text Key: 245147016
• Report Number: 3009211636-2021-00743
• 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
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8888160531
• Device Catalogue Number: 8888160531
• Device Lot Number: 201 1900052
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/08/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other