MAUDE Adverse Event Report: COVIDIEN 3.5FR URETHANE UMB CATH; CATHETER, UMBILICAL ARTERY

Model Number 8888160333

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/09/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer reported that a uac size 3.5fr was inserted in a neonatal patient on (b)(6) 2021 at 4:00pm.Then an x-ray was done to check the position of the uac that showed the uac coiled downwards in the wrong position.The uac was anchored at 20cm and sutured to the umbilical.At 12 midnight when intending to remove the uac while getting ready for another procedure, it was noted that the uac had snapped and broken off at 17cm and remained inside the baby's body.They were unable to identify the balance of the uac within the umbilical.The baby passed away on (b)(6) 2021.Additional information has been requested from the initial reporter but at this time, no further information has been provided.

Manufacturer Narrative

The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.The reported lot number was manufactured on 20-october-2018.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.One used catheter was received for the evaluation.Upon visual examination, the catheter of the uvc was broken off at 17 cm with a clean cut (without stretch marks); therefore, the reported condition was confirmed.As only a portion of the catheter tube was received (after the 17 cm mark), the section of the tube from 5 cm mark to the 17 cm mark was not able to be investigated.The returned catheter was measured to verify the tube outside diameter, inside diameter and the wall thickness.All dimensions were found within the manufacturing process specification.The tensile test was performed to verify the necessary force to break the catheter; the returned sample passed the test.An ishikawa diagram was used to determine the potential root cause of the reported issue.Based on the results, the catheter may have been damaged by sharp-edged instruments during clinical use, resulting in catheter breakage; therefore, the most probable root cause can be considered as misuse, as a clean cut with a sharp instrument was observed in the sample received.It is important to consider that according to the instructions for use warning, ¿do not use instruments with sharp or rough edges directly on the catheter since even a minor cut could tear or break the catheter¿.The reported issue is not related to manufacturing process and no trends was identified.At this time, a corrective and preventive action is not deemed necessary.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.

• Brand Name: 3.5FR URETHANE UMB CATH
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• Manufacturer (Section G): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 11467733
• MDR Text Key: 239287656
• Report Number: 3009211636-2021-00741
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 20884527005113
• UDI-Public: 20884527005113
• Combination Product (y/n): N
• Reporter Country Code: MY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/20/2023
• Device Model Number: 8888160333
• Device Catalogue Number: 8888160333
• Device Lot Number: 1828300096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 1 DA