MAUDE Adverse Event Report: COVIDIEN UNKNOWN NEONATAL; UMBILICAL VESSEL CATHER

Model Number UNKNOWN NEONATAL

Device Problem Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

Submit date: 2/29/2016.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with an umbilical vessel catheter (uvc).The customer states that the catheter is folding back on itself after being inserted into the patient.The customer states they are unable to get the correct placement.After placing the line, they felt it was placed correctly, but in checking the x-ray found that it had flipped back on itself.After removing the line, the uvc did not appear to be damaged in any way and had flipped back to straight.The customer stated that the uvc had to be pulled and replaced.There was no harm or medical intervention.

Manufacturer Narrative

The complaint sample was not returned to the manufacturing site for review.The lot number was not provided.All device history record (dhr) are reviewed for accuracy prior to product release.Because the sample was not returned, there is not enough evidence to determine what could cause this event.The following potential causes were identified either to this document operator error, instructions for use (ifu)¿s not followed: connections, infused substances, inspection not performed adequately, material composition.However, without the sample it is not possible to determine a specific root cause for this issue.Should the sample be returned in the future, this complaint will be re-opened for further investigation.There are no triggers or trends found for this event therefore no further actions are required for this investigation.It must be noted that in-process controls such as personnel training, incoming quality acceptance testing for raw material, in process visual inspection and visual acceptance sampling are in place to prevent nonconforming product from leaving the manufacturing operations, environmental and product biological monitoring.This complaint will be used for tracking and trending purposes.

• Brand Name: UNKNOWN NEONATAL
• Type of Device: UMBILICAL VESSEL CATHER
• Manufacturer (Section D): COVIDIEN; covidien manufacturing solutions sa; edificio 820 calle #2 zona france coyol; alajuela ; CS
• Manufacturer (Section G): COVIDIEN; covidien manufacturing solulfons sa; edificio 820 calle #2 zona franca coyol; alajuela 20101 ; CS 20101
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5466525
• MDR Text Key: 39238754
• Report Number: 3009211636-2016-00102
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN NEONATAL
• Device Catalogue Number: UNKNOWN NEONATAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other