MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR CUSTOM DEFINED PRODUCT; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number VO3906TSPL03

Device Problem Particulates (1451)

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

Event Date 12/18/2015

Event Type  malfunction  

Manufacturer Narrative

The lot number was not provided; therefore, a review of the manufacturing records could not be completed.A supplemental report of the evaluation will be forthcoming when the results are completed.

Event Description

It was reported that an unknown plastic-like material was observed in the monitoring line during use.This was found while releasing the air of the cannula after the cannula was connected to the patient.The exact location of the material is unknown, but was noticed inside the lumen.There were no patient complications reported.

Manufacturer Narrative

As received into the deco laboratory, blood was visible in the iv tube, dpt, vamp and pressure line.The iv tube was cut and proximal end of the tube was tied up.No visible particulate or plastic-like material was observed throughout the kit during pre-deco evaluation.The iv tube was untied, and then fluid path was flushed manually using syringe from the laboratory.No particulate was flushed out from the kit or remained inside of the kit.No particulate was flushed out during decontamination process.The kit was moved to product evaluation laboratory and then further examination was performed.No visible particulate or plastic-like material was observed throughout the kit during visual examination.Kit was flushed continuously for 5 minutes and no visible particulate or plastic-like material was flushed out from the kit.A review of the manufacturing records indicated that the product met specification at the time of release.

• Brand Name: CUSTOM DEFINED PRODUCT
• 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: lynn selawski ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 5324244
• MDR Text Key: 34276214
• Report Number: 2015691-2015-03517
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2015

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: 07/31/2017
• Device Model Number: VO3906TSPL03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/05/2016
• 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