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

Model Number VJ4304TS_

Device Problems Device Damaged Prior to Use (2284); Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 05/15/2019

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 observed inside of the connector in an opened pouch before use.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

The ir spectrum of the black particulate noted in the disposable pressure transducer male luer connector could not be determined due to its microscopic size coupled with low absorbance energy.

Manufacturer Narrative

One single dpt-vamp jr.Kit with pressure tubing was returned for examination.The reported event of ¿unknown black particulate was observed inside the connector¿ was confirmed.Several unknown black materials were observed on the male luer of the dpt zero-stopcock located inside of the connection to the female connector of the pressure line.The largest material was approximately 1.0 x 0.5 mm in size, and the others were less than 0.5 mm in size.The materials stayed at the same location on the male luer after 5 minutes of continuous flushing.A review of the manufacturing records indicated that the product met specifications upon release.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.A supplemental report will be forthcoming when the chemistry results are completed.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 particulate was noticed before use.Chemistry results are pending.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.

Manufacturer Narrative

The investigation of the unknown black particulate found inside the connector 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

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: 8680584
• MDR Text Key: 147878735
• Report Number: 2015691-2019-02074
• 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: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2023
• Device Model Number: VJ4304TS_
• Device Lot Number: KP0680MT
• 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