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

Model Number 8888160333

Device Problem Break (1069)

Patient Problems Blood Loss (2597); Foreign Body In Patient (2687)

Event Type  Injury  

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 reopened and responded to accordingly.

Event Description

The customer reported the neonatal fellow was removing an umbilical artery vessel catheter (uvc) after discontinuation of fluids from the umbilical artery of a 3 day old patient.The sutures were cut and the part of the umbilical artery that had adhered to the catheter was peeled away.The umbilical vein vessel catheter was removed first and without incidence.While slowly removing the catheter with the catheter between her thumb and forefinger, the first 7cm of the catheter was able to be pulled out of the vessel without difficulty.While attempting to remove the last 5cm of the catheter, the catheter broke off at the umbilical stump.Pressure was immediately applied to the site and a hemostat was used to stop blood loss.A stat x-ray and surgical consult were done.After viewing the x-ray, surgery was able to remove the remaining catheter via the remaining umbilical stump.Estimated blood loss at 12 milliliters.The patient received normal saline (nss) bolus during the procedure.

• 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: 9489081
• MDR Text Key: 176840612
• Report Number: 3009211636-2019-00679
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 20884527005113
• UDI-Public: 20884527005113
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8888160333
• Device Catalogue Number: 8888160333
• Device Lot Number: 1916800103
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 3 DA