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

Model Number TC0160TA_

Device Problems Contamination (1120); Device Contamination with Chemical or Other Material (2944)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/30/2019

Event Type  malfunction  

Manufacturer Narrative

One pressure tubing was returned for examination.The reported event of ¿unknown black particulates were found on the tubing¿ was confirmed.One black material was observed inside of the tubing, on the pressure tubing wall.The material was approximately 0.5 x 0.5 mm in size.The material stayed at the same location on the pressure tubing wall after 5 minutes of continuous flushing.The pressure tubing was cut, and the material was found embedded within the tubing wall, but a part of the material surface seemed to be exposed from the wall.Lot number was not provided, therefore review of the manufacturing records could not be completed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.The ir spectrum of the black particulate noted in the disposable pressure transducer tubing observed before use showed a similar absorption characteristic when comparing to pvc like material, of which the tubing is made.It is common clinical practice to inspect all products before usage.Additionally, these products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised to consider the potential benefits in relation to the possible complications.In this case the particulates were found before the unit was connected to the patient.The particulate was pvc like material which is the material that the dpt is made of.The noted particulate was not able to be flushed out during 5 minutes of continuous flushing.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 part of this monthly review.

Event Description

It was reported that unknown black particulates were found on the tubing in an opened package of a disposable pressure transducer before use.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

The investigation of the unknown black particulate found inside of the pressure tubing of a dpt (disposable pressure transducer) found that the potential root cause for this nonconformance could be a supplier material defect.As this defect cannot be generated at our manufacturing process, the supplier was notified.

Manufacturer Narrative

Reference capa-20-00141.

• 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 ; DR
• MDR Report Key: 8818461
• MDR Text Key: 154111539
• Report Number: 2015691-2019-02725
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TC0160TA_
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1