MAUDE Adverse Event Report: COVIDIEN UNKNOWN NEONATAL; CATHETER, UMBILICAL ARTERY

Model Number UNKNOWN NEONATAL

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 06/01/2020

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.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that during infant's care time, it was observed that blood was backing up from the uvc that then started to leak at the junction in the umbilical venous catheter right before the posi-flow and blood started to leak onto the infant's blanket covering the mattress.Per the customer, no additional information is available.

• Brand Name: UNKNOWN NEONATAL
• 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: 10399525
• MDR Text Key: 202712099
• Report Number: 3009211636-2020-00712
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UNKNOWN NEONATAL
• Device Catalogue Number: UNKNOWN NEONATAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/31/2020
• Type of Device Usage: N
• Patient Sequence Number: 1