MAUDE Adverse Event Report: COVIDIEN 5FR DUAL-LUMEN UVC CATH; CATHETER, UMBILICAL ARTERY

Model Number	8888160556
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation, therefore, a failure analysis is not available, and we are not able to determine the relationship between this device, and the cause for this event.As part of our manufacturing process, all device history records are reviewed, and approved by quality, prior to release of product.If additional information, or the sample is received, the investigation will be re-opened, and responded to accordingly.
Event or Problem Description
The customer reported that while checking for resistance, the catheter snapped causing +- 10 cm to be retained within the patient.Additional information provided on 2-dec-2020 stated that the patient had to be referred to a cardiologist in (b)(6) to undergo open heart surgery to remove the catheter.It snapped at the 10cm mark just outside the umbilical cord as they tested for resistance.Additional information provided by the customer on 8-dec-2020 stated that chlorhexidine/saline was used to clean the area prior to insertion.The area was completely dry prior to insertion on (b)(6) 2020 into the uvc.It was secured with 3.0 stitches and to the responder's knowledge it was not difficult to secure.The line was flushed on a regular basis with neocyte infusion/water for injection before insertion, neocyte infusion after insertion.Chlorhexidine/saline was used to clean the cord.Webcol on the hub.The uvc broke on (b)(6) 2020, and the retained uvc was surgically removed on (b)(6) 2020.The device was not replaced.Besides the retainment there was no injury to the patient.Additional medical intervention required was intubation, ventilation, after extubation, oxygen therapy, pericardial and thoracic drains, urinary catheter and central lines inserted.Inotropes, sedation and antibiotic therapy.The patient is currently on room air and establishing suck feeds.The patient's date of birth was (b)(6) 2020, male, birth weight: (b)(6) kg.
Additional Manufacturer Narrative
Updated h1: type of reportable event from malfunction to serious injury.

• Brand Name: 5FR DUAL-LUMEN UVC CATH
• Common Device Name: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• MDR Report Key: 10998506
• Report Number: 3009211636-2020-00729
• Device Sequence Number: 19020851
• Product Code: FOS
• UDI-Device Identifier: 20884527005182
• UDI-Public: 20884527005182
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 08/27/2024
• Device Model Number: 8888160556
• Device Catalogue Number: 8888160556
• Device Lot Number: 1926700124
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 12/13/2020
• Supplement Report FDA Received Date: 02/09/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 7 DA