MAUDE Adverse Event Report: COVIDIEN 5FR DUAL-LUMEN UVC CATH; UMBILICAL VESSEL CATHETER

Model Number 8888160556

Device Problem Leak/Splash (1354)

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

Event Date 06/01/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 06/27/2016.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 a dual lumen umbilical vessel catheter.The customer states the uvc is leaking around the hub.

Manufacturer Narrative

(date of this report): originally reported as 06/01/2016 and should be 01/01/2015.Additional clarification regarding the notification date was received from the sales representative; however, the exact date in january is unknown, the date selected does not represent the exact date we were notified.

Manufacturer Narrative

The actual sample involved in the reported incident was not returned for evaluation.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.A device history record (dhr) review revealed no discrepancies that may have contributed to a complaint of this failure mode.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met specification requirements.In addition, all dhrs 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 available information was analyzed and it did not allow a confirmed root cause for the event.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: 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: 5752570
• MDR Text Key: 48882821
• Report Number: 3009211636-2016-00282
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888160556
• Device Catalogue Number: 8888160556
• Device Lot Number: 1519800081
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2016
• 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