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

Model Number 8888160333

Device Problem Leak/Splash (1354)

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

Event Date 07/17/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 08/05/2016.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 reports the uvc was inserted (b)(6) 2016, used for perineal nutrition.The catheter was found to be leaking later the same day.The catheter is leaking at the hub end of the catheter.

Manufacturer Narrative

Submit date: 11/07/2016.The actual sample involved in the reported incident was not returned for evaluation.Since no sample was returned for examination, it was not possible to evaluate it as part of a comprehensive failure investigation.If the sample is returned in the future, this complaint will be re-opened for further investigation.As no lot number was identified, a manufacturing device history review (dhr) or product/process changes review for the involved lot number could not be performed.However, all dhrs are reviewed for accuracy prior to product release.The available information was analyzed and it did not allow confirming a root cause for the event, however, dfmea was reviewed in order to identify the possible causes for the failure: leak below strain relief.The most probable root causes could be due to an issue with over bending, excessive force, improper use of sharp objects, a machine malfunction, inspection failed or not performed and/or defective material.No trends or triggers have been found, therefore, a corrective or preventive action is not deemed necessary at this time.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for (b)(4), 100% in process visual inspection and visual acceptance sampling are performed in the plant) are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• 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 solulfons sa; edificio 820 calle #2 zona franca coyol; alajuela 20101 ; CS 20101
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5852174
• MDR Text Key: 52491857
• Report Number: 3009211636-2016-00337
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888160333
• Device Catalogue Number: 8888160333
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2016
• 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