MAUDE Adverse Event Report: COVIDIEN 5.0FR URETHANE UMB CATH; CATHETER, UMBILICAL ARTERY

Model Number	8888160341
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Tachycardia (2095); Blood Loss (2597)
Date of Event	02/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
The customer reported that there was blood leaking from the catheter and a new line had to be replaced since the patient lost 6-7ml of blood, they had caught it before further blood loss.
Event or Problem Description
Additional information received stated that the patient went into svt 4 times during their shift (all of the svt episodes occurred before we noticed the cracked uvc).And they had to give adenosine 4 times to get the baby back into normal sinus rhythm.After the 3rd episode of svt, the physician thought the uvc was too deep (thus irritating the heart and causing svt), so they pulled it back and re-sutured it in place, the baby again had another episode of svt and after the physician pulled back the uvc, they noticed that the uvc was cracked.
Additional Manufacturer Narrative
Additional detailed information related to the event as provided by the customer.Additional patient code added based on additional information provided by the customer.

• Brand Name: 5.0FR URETHANE UMB CATH
• Common Device Name: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• MDR Report Key: 9740707
• Report Number: 3009211636-2020-00687
• Device Sequence Number: 11256295
• Product Code: FOS
• UDI-Device Identifier: 20884527005120
• UDI-Public: 20884527005120
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2020

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 Model Number: 8888160341
• Device Catalogue Number: 8888160341
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 03/31/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other