MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING KIT; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number PXVFP11100

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/10/2022

Event Type  Injury  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.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 a part of the monthly review.

Event Description

It was reported that when the customer tried to connect the luer at the distal end of the kit to a surflo iv catheter manufactured by terumo, the luer finally spun around on the first day of use.It was able to attach the luer to a jelco iv catheter manufactured by smiths medical.The jelco iv catheter required a new access site.There were no patient complications reported.Patient demographic information requested but unavailable.

Manufacturer Narrative

The reported issue with distal tubing male connector was not able to be confirmed.No visible damage or defect was observed from the kit, especially distal tubing male connector, during visual examination.No connection issue was observed between the distal tubing male connector and catheter needle from lab.Planecta with one way stopcock was connected to kit for further leak test.No leakage was observed from the kit during leak test.No luer connection got loose or detached during evaluation.Further evaluation regarding supplier related quality issues is under investigation.A device history record review was completed and documented that device met all specifications upon distribution.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 a part of the monthly review.

Manufacturer Narrative

Further evaluation regarding supplier related quality issues is completed.Per investigation summary, no abnormality like damage or deformation was observed on male connector and its lock nut.The male connector passed iso594 2 standards.Production and inspection records for reported lot were reviewed, but no abnormality was recorded.Per above investigation, it was considered that this issue was not related to product nonconformance.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 a part of the monthly review.

• Brand Name: PRESSURE MONITORING KIT
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 15014827
• MDR Text Key: 295882843
• Report Number: 2015691-2022-06771
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 01/03/2024
• Device Model Number: PXVFP11100
• Device Lot Number: XC0730MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/24/2022
• Initial Date FDA Received: 07/14/2022
• Supplement Dates Manufacturer Received: 07/19/2022; 09/05/2022
• Supplement Dates FDA Received: 08/09/2022; 09/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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