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

Model Number X3820SJD

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2020

Event Type  malfunction  

Manufacturer Narrative

The presep catheter evaluation is in progress.A supplemental report will be sent with the investigation results.A device history record review was completed and documented that device met all specifications upon distribution.

Event Description

It was reported that unknown dirt was found on the needle during priming.When the customer touched the dirt, it came off from the needle.The customer commented that it looked like rust.The size of the dirt is unknown.The needle will be returned for evaluation, but the dirt like material which came off from the needle will not be returned.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

One presep oximetry central venous catheter kit was returned for evaluation with various components on the original tray.As received, package had been opened.As received, the pouch of the curved needle was opened and taped on the tyvek sheet.It could not be confirmed if the customer complained about the puncture needle or the curved needle; therefore, all six needles from the returned kit were examined during evaluation.No visible contamination was observed on the returned needles or tray during visual examination.Visual examinations were performed under microscope at 10x magnification.Customer report of contamination issue on needle could not be confirmed during the evaluation.There was no evidence of a manufacturing nonconformance.No further actions will be taken at this time.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the catheter, to consider the potential benefits in relation to the possible complications.The techniques for insertion, methods of using the catheter to obtain patient data information, and the occurrence of complications is well described in the literature.In this case it is unknown whether any user or procedural factors may have contributed to the stated event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

• Brand Name: PRESEP CENTRAL VENOUS OXIMETRY KIT
• Type of Device: PRESEP CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 10437913
• MDR Text Key: 204570503
• Report Number: 2015691-2020-13248
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• PMA/PMN Number: K053609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/04/2020

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: 11/20/2021
• Device Model Number: X3820SJD
• Device Lot Number: 62749304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Initial Date Manufacturer Received: 08/04/2020
• Initial Date FDA Received: 08/21/2020
• Supplement Dates Manufacturer Received: 08/21/2020
• Supplement Dates FDA Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1