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

Model Number PL4003TS01

Device Problems Contamination of Device Ingredient or Reagent (2901); 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 08/16/2019

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 an unknown black particulate was found inside of the iv tubing of a pressure monitoring kit before use.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

One iv set with priming solution was returned for examination.The reported event of contamination issue was confirmed.One unknown gray material was observed inside of the iv tubing, at approximately 5cm proximal from iv tubing male connector.The gray material was approximately 1.5mm x 1.0mm in size.The material seemed stuck to the inner wall of the iv tubing and stayed at the same location inside of the iv tubing after 5 minutes of continuous flushing.Chemistry results of a particulate that was found inside of the iv tubing indicated that the ir spectrum of the unknown gray material showed similar absorption characteristics when comparing to polypropylene like material.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint, including if polypropylene material from the chemistry findings is associated with any component of the manufacturing process.A supplemental report will be sent with the investigation results.A review of the manufacturing records indicated that the product met specifications upon release.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

Per infus investigation the finished product goes through a 100% inspection, all related operators who perform tube cutting, and bonding inspection have been properly trained and qualified.The tube cutting machine and the glue applicator used for bonding has been checked and could not be the source of the contamination.There is no cause or indication that polypropylene material contamination could be related to the infus process.

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: 8975656
• MDR Text Key: 197782116
• Report Number: 2015691-2019-03365
• 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
• Report Date: 08/19/2019

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: 03/31/2021
• Device Model Number: PL4003TS01
• Device Lot Number: LH1461MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Initial Date Manufacturer Received: 08/19/2019
• Initial Date FDA Received: 09/09/2019
• Supplement Dates Manufacturer Received: 10/15/2019; 11/12/2019; 07/23/2020
• Supplement Dates FDA Received: 10/28/2019; 11/15/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1