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

Model Number PXVFZ10783

Device Problem Contamination (1120)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/22/2022

Event Type  malfunction  

Event Description

It was reported that there was unknown glue like material on the luer connector on the distal end of a pressure monitoring kit and caused 1 to 2cc of blood leakage on the first day of use.The customer proceeded manipulation although the foreign material was recognized during preparation.Blood got stuck at the luer connector and leaked.The customer commented that priming could be performed but not sure.The patient was an adult.There were no patient complications reported although blood leakage was observed.

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.

Manufacturer Narrative

The reported event of gluelike material on the luer connector on the distal end was confirmed.White material was observed on distal tubing male connector.Pressure tubing is bonded with the male connector with bonding solvent, a mixture of cyclohexanone and mek.No chemistry analysis was performed since the white material was contaminated with dry blood.It was not able to establish tight connection between the male connector and catheter needle from lab due to the white material.It appeared that the white material had interfered tight connection between the luers and create leakage path.The white material did not dislodge during evaluation.Further evaluation regarding related supplier 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

The subject device component was sent to the third party manufacturer for evaluation.The root cause of the adherent material was determined to be a leakage of solvent bonding onto the connector during bonding solvent application.Corrective actions are in progress at the third party manufacturer.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: jessica atallah ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 15402247
• MDR Text Key: 305084237
• Report Number: 2015691-2022-07827
• 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: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/18/2024
• Device Model Number: PXVFZ10783
• Device Lot Number: XF1228MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2022
• 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