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

Model Number VO2402TSPL

Device Problem Particulates (1451)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/28/2016

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However the complaint could not be confirmed without the completion of the product evaluation.A supplemental report will be forthcoming with the evaluation results.

Event Description

It was reported that an unknown particulate was observed inside the fluid lumen of the iv tubing before use.There were no patient complications reported.

Manufacturer Narrative

A review of the manufacturing records indicated that the product met specification at the time of release.One single dpt-vamp flex kit with iv set and pressure tubing was received.Examination revealed black marks on the iv tubing surface.The location of the marks could not be measured due to the iv tubing being coiled with the paper band.It was also noted that the black ink of the vamp flex syringe came off.There was no particulate observed throughout the kit during visual examination.

• Brand Name: DISPOSABLE PRESSURE TRANSDUCER
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; carretera sanchez, km 18 1/2; parque ind. de itabo; haina. san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; carretera sanchez, km 18 1/2; parque ind. de itabo; haina. san cristobal ; DR
• Manufacturer Contact: brian hurd-servin ; 1 edwards way; irvine, CA 92614 ; 9492506423
• MDR Report Key: 5817627
• MDR Text Key: 50304749
• Report Number: 2015691-2016-02319
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2016

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 Model Number: VO2402TSPL
• Device Lot Number: HE1027MT
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/11/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/28/2016
• Initial Date FDA Received: 07/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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