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

Model Number 8888160333

Device Problems Fluid/Blood Leak (1250); Kinked (1339); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 12/16/2016.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

Malfunction it was reported to covidien on (b)(6) 2016 that an issue occurred with the customer reports a uvc that was leaking just above the butterfly where the extension tubing meets the butterfly.The customer stated that when staff needs to disconnect the syringe to attach the iv tubing they have to clamp the uvc so there is no air entering the line or back flowing of blood.There is no device to clamp the uvc so they kink the line.This often leads to cracking and leaking from the line causing a new line to have to be placed.No harm to the patient.

• Brand Name: 3.5FR URETHANE UMB CATH
• Type of Device: UMBILICAL VESSEL CATHETER
• Manufacturer (Section D): COVIDIEN; covidien manufacturing solutions sa; edificio 820 calle #2 zona france coyol; alajuela ; CS
• Manufacturer (Section G): COVIDIEN; covidien manufacturing solutions sa; edificio 820 calle #2 zona france coyol; alajuela ; CS
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6183525
• MDR Text Key: 62959594
• Report Number: 3009211636-2016-00501
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8888160333
• Device Catalogue Number: 8888160333
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1