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

Model Number X3820HSJD

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2016

Event Type  malfunction  

Manufacturer Narrative

One triple lumen presep catheter kit with all components including packaging was returned for evaluation.As received, one side of shelf box was opened, and tyvek sheet was also opened from the tray.An insect was found stuck on the inner surface of tyvek sheet.The insect seemed to be crushed to tyvek sheet and a stain was also observed on the other side of tyvek sheet, where the insect was found.The insect was approximately 3mm x 4mm in size.No visible damage tyvek sheet or tray 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 ¿insect was stuck to the inner surface of the tyvek sheet¿ was confirmed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.This model number is exclusively sold in the (b)(4) market; therefore, this is a regional recall only.

Event Description

It was reported that a mosquito or fruit fly-like insect was stuck to the inner surface of the tyvek sheet when the customer opened the product in the icu.The product was not used on a patient.There were no patient complications reported.

• Brand Name: PRESEP CENTRAL VENOUS OXIMETRY SET
• Type of Device: PRESEP CATHETER KIT
• 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 PR 00610
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 5439801
• MDR Text Key: 38284630
• Report Number: 2015691-2016-00461
• 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,o
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/20/2016

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: 02/04/2017
• Device Model Number: X3820HSJD
• Device Lot Number: 60122473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2016
• Initial Date FDA Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2015
• 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