MAUDE Adverse Event Report: COVIDIEN ARGYLE; CATHETER, UMBILICAL ARTERY

Model Number 8888160333

Device Problem Leak/Splash (1354)

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

Event Date 12/04/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 05/19/2017.An investigation is currently underway.Upon completion, the results will be forwarded.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports a uvc (umbilical vessel catheter) was placed.Right after placement the uvc was leaking just below the hub where the catheter is joined.The uvc was clamped and discontinued.The customer further reported that alcohol is used to clean only the actual hub.

Manufacturer Narrative

The actual sample involved in the reported incident was not returned for evaluations.No additional information, pictures or videos were received.Since no sample was returned for examination, it was not possible to evaluate it as part of a comprehensive failure investigation.As no lot number was identified, a manufacturing device history review or product/process changes review for the involved lot number could not be performed.However, all device history records (dhr)s are reviewed for accuracy prior to product release.If the sample is returned in the future, this complaint will be re-opened for further investigation.The products specifications were reviewed in order to identify the possible causes for the deficiency reported; leaking.The following potential causes were identified in the pfmea/dfmea or in addition to this document: unintentional customer misuse if an inspection in process failed or was not performed to identify defective material when using a sharp instrument near or with a catheter.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 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.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARGYLE
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20, calle #2; alajuela 0101
• Manufacturer (Section G): COVIDIEN; edificio b20, calle #2; alajuela 0101
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6577838
• MDR Text Key: 75528349
• Report Number: 3009211636-2017-05111
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2017
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1