MAUDE Adverse Event Report: COVIDIEN 5FR TRPL-LUMN UMB VSL CATH; CATHETER, UMBILICAL ARTERY

Model Number 8888160648

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2021

Event Type  malfunction  

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 states that a cardiac patient had a triple lumen umbilical vessel catheter and after placement, multiple fluid boluses and drops were ordered.The providers requested the bedside nurse hand push boluses instead of running them on a pump.The nurses had a hard time pushing the meds because there was a lot of resistance.It was discovered that there was a crack in the tertiary lumen after the echo tech felt the fluid from the boluses splashing him.The neonatal nurse practitioner was notified, and replaced the triple lumen umbilical vessel catheter with another.

• Brand Name: 5FR TRPL-LUMN UMB VSL 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 ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 11986376
• MDR Text Key: 255783230
• Report Number: 3009211636-2021-00753
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 20884527005199
• UDI-Public: 20884527005199
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8888160648
• Device Catalogue Number: 8888160648
• Device Lot Number: 1921900151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/03/2021
• Type of Device Usage: N
• Patient Sequence Number: 1