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

Model Number UNKNOWN NEONATE

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Type  malfunction  

Manufacturer Narrative

Submit date: 03/18/2016.An investigation is currently underway.Upon completion, the results will be forwarded.Several attempts to gather information from the customer were made.To date, no response has been received.If additional pertinent information becomes available, the report will be updated.

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 reports that the tip of an umbilical catheter broke off inside of a (b)(6) baby.It was unknown what the results of the cath lab were.There was no injury reported.The product was administered sometime in 2005, no other information was given.

Manufacturer Narrative

A lot number was not provided, therefore, it is not possible to perform a device history record (dhr) review.All dhr¿s 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.Because the sample was not returned, there is not enough evidence to determine what could have caused this event.The following possible causes for the failure may be attributed to: 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.In-process controls such as personnel training, incoming quality acceptance testing for raw material, 100 in process visual inspection and visual acceptance sampling are in place to prevent nonconforming product from leaving the manufacturing operations.As per product specification, manufacturing performs 100% pressure testing during production, which would identify this issue in the catheter assembly.This complaint will be used for tracking and trending purposes.

• Brand Name: UNKNOWN NEONATAL
• 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 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: 5510849
• MDR Text Key: 40948563
• Report Number: 3009211636-2016-00126
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN NEONATE
• Device Catalogue Number: UNKNOWN NEO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2016
• 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