MAUDE Adverse Event Report: COVIDIEN 3.5FR DUAL-LUMEN UVC CATH; UMBILICAL VESSEL CATHETER

Model Number 8888160531

Device Problems Hole In Material (1293); Leak/Splash (1354)

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

Event Date 08/16/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 09/01/2016.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on 08/25/2016 that a customer had an issue with a dual lumen umbilical vessel catheter (uvc).The customer reports the y-junction of the two ports, the line leaked when flushing the 20g primary (clear) side, but did not leak when flushing 23g the secondary (blue) side.There appears to be a hole or gouge in the line at the point of leaking.The umbilical catheter has a hole in it.

Manufacturer Narrative

Date of event: originally reported as (b)(6) 2016 and should be (b)(6) 2016.Additional information was received from the customer.Please see section for the additional information received.

Event Description

The customer further reported that betadine was used to clean the skin area and the area completely dried prior to insertion.There were no difficulties noted in line placement.It was not difficult to secure.The uvc was inserted (b)(6) 2016 in the resuscitation room.Each line was flushed on a regular basis, which is standard practice.Either a 12ml ns or 6ml heparin was used to flush the lines depending on what was used.Chg was used to clean the connector only, the tubing was not cleaned.The uvc was removed (b)(6) 2016.A piv was placed until additional central access could be obtained.Patient is still in-patient.

• Brand Name: 3.5FR DUAL-LUMEN UVC 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 street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5922581
• MDR Text Key: 54420620
• Report Number: 3009211636-2016-00365
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888160531
• Device Catalogue Number: 8888160531
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1