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

Model Number PL3405TW01

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 12/25/2019

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.

Event Description

It was reported that there was black particle floating in the yellow line before use.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

One double dpt kit with pressure tubing and a trifurcated iv set were returned for examination.The reported event of contamination issue was confirmed.One brown material was observed inside of the yellow pressure tubing, on the inner tubing wall at approximately 20cm distal from the dpt zero-stopcock.The brown material was approximately 0.5mm x 0.5mm in size.The material stayed at the same location inside of the pressure tubing after 5 minutes of continuous flushing.The pressure tubing was cut, and a part of the material was found embedded within the inner tubing wall.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.A supplemental report will be forthcoming with the chemistry and device history results when received.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.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 a part of the monthly review.

Manufacturer Narrative

The ir spectrum of the brown material noted in the pressure tubing showed a similar absorption characteristic when comparing to pvc like material.The noted particulate was not able to be flushed out during 5 minutes of continuous flushing.A review of the manufacturing records indicated that the product met specifications upon release.

Manufacturer Narrative

Investigation found that the potential root cause for this nonconformance could be a supplier related material.A supplier notification was made to tekni-plex the manufacturer about this finding.

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: 9586855
• MDR Text Key: 188654214
• Report Number: 2015691-2020-10171
• 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,Followup,Followup
• Report Date: 12/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2023
• Device Model Number: PL3405TW01
• Device Lot Number: LJ0294MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1