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

Model Number	8888160648
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
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 reopened and responded to accordingly.
Event or Problem 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
• Common Device Name: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• MDR Report Key: 11986376
• Report Number: 3009211636-2021-00753
• Device Sequence Number: 4637114
• Product Code: FOS
• UDI-Device Identifier: 20884527005199
• UDI-Public: 20884527005199
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 8888160648
• Device Catalogue Number: 8888160648
• Device Lot Number: 1921900151
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 06/11/2021
• Patient Sequence Number: 1