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

Model Number PXMK10272

Device Problems Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 07/17/2020

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 unknown plastic-like material was found inside the 4-way stopcock, before use, of this disposable pressure transducer.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

One single dpt with iv set and pressure tubing was received for evaluation.The reported event of ¿plastic inside stopcock¿ was confirmed.As received, what appeared to be broken tip of non-ew syringe was found at female luer of stand-alone three-way stopcock.The broken tip remained inside the female luer of stand-alone three-way stopcock.Cross surfaces of the tip at the site of damage appeared twisted.No other visible defect/damage was observed from the returned kit, especially female luer of stand-alone three-way stopcock, during visual examination.Further evaluation: the broken piece of what appeared to be a tip of the syringe was removed from the female luer of stand-alone stopcock.Both female luers of the stand-alone stopcock dimensionally passed the iso standard.Further analysis is pending for any non conformance related to the manufacturing process.A device history record review was completed and documented that device met all specifications upon distribution.It is common clinical practice to inspect all products before usage.In this case, the tip of a non-ew syringe was stuck in the stopcock.The broken syringe tip would not have migrated into the tubing to cause any patient injury.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.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.No corrective or preventative actions are required at this time.

Manufacturer Narrative

Corrected data: f10, h6.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: 10381382
• MDR Text Key: 205340846
• Report Number: 2015691-2020-12987
• 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: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/24/2023
• Device Model Number: PXMK10272
• Device Lot Number: LS1403MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1