MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE TUBING WITH 3 WAY STOPCOCK; TRANSDUCER, BLOOD PRESSURE, EXTRAVASCULAR

Model Number 58K16906

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/07/2022

Event Type  malfunction  

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.The lot number was not provided thus a device history record was not reviewed.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 the pressure tubing got detached at the connection with the three way stopcock, which caused blood leakage on the first day of use.The event occurred to an adult patient and although the exact amount of blood leakage was unknown, neither any additional treatments nor extension of hospitalization was needed.The device was exchanged and the problem was solved.Although there was blood leakage observed, there were no patient complications reported by the customer.

Manufacturer Narrative

Additional testing was completed.The tubing od, 0.1110" near the point of detachment, was within specification.Stopcock tubing housing id was not able to be measured due to presence of bonding material on the inner wall.Further evaluation regarding related quality issues is under investigation.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 pressure tubing got detached at the connection with the three way stopcock was confirmed.As received, pressure tubing was detached from three way stopcock.Bond indication was observed on inserted portion of the detached tubing.Further evaluation regarding related quality issues is under investigation.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 TUBING WITH 3 WAY STOPCOCK
• Type of Device: TRANSDUCER, BLOOD PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 15710523
• MDR Text Key: 304824763
• Report Number: 2015691-2022-08939
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K832907
• 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: 12/19/2022

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 Model Number: 58K16906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/11/2022
• Initial Date FDA Received: 11/01/2022
• Supplement Dates Manufacturer Received: 11/07/2022; 12/01/2022
• Supplement Dates FDA Received: 11/23/2022; 12/19/2022
• 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