MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR PRESEP CENTRAL VENOUS OXIMETRY SET; PRESEP CATHETER

Model Number X3820HSJD

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2015

Event Type  malfunction  

Event Description

It was reported that hair-like material was attached to the gauze before use.There were no patient complications reported.

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.

Manufacturer Narrative

One opened presep catheter kit pouch was returned for evaluation.No gauze, catheter, or packaging was returned.No visible hair or other particulate was found inside the returned pouch.No visible defect to the returned pouch was observed.Visual examinations were performed under microscope at 10x magnification.A device history record review was completed and documented that device met all specifications upon distribution.Customer report of ¿hair-like material was attached to the gauze¿ could not be confirmed during the analysis, as the gauze and packaging were not returned.No further actions will be taken at this time.

• Brand Name: PRESEP CENTRAL VENOUS OXIMETRY SET
• Type of Device: PRESEP CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco CA 00610
• Manufacturer Contact: lynn selawski ; one edwards way; irvine, CA 92614 ; 9492504386
• MDR Report Key: 4910716
• MDR Text Key: 6032036
• Report Number: 2015691-2015-01680
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K053609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2015
• Device Model Number: X3820HSJD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/19/2015
• Initial Date FDA Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1