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

Model Number PXVJ356

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 02/28/2019

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 when the sterile package was opened, a disconnection between the z-site and the distal tubing was observed on a vamp jr.No patient involvement.Follow up attempts were made for product return without success to date.

Manufacturer Narrative

One single dpt - vamp jr.Kit was returned for examination.The reported event of "disconnection between the z-site and the distal tubing" was confirmed.The pressure tubing was found broken from the bond joint with a sample site.The distal end of the broken tubing was not returned; however the tubing was visible in a customer photo.The cross surfaces of the broken tubing inside of the sample site appeared rough and uneven.No other visible damage was observed from returned kit.A review of the manufacturing records indicated that a related non-conformance was found.The lot impacted was placed on hold.It was concluded that the cracking of the material was related to the supplier process.The supplier was notified.It is common clinical practice to inspect all products before usage.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to use the system, to consider the potential benefits in relation to the possible complications.These products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise during use.In addition, these devices are typically used in intensive care units or operating rooms, where patients are closely monitored.In this event, there was no patient involvement.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.Udi# (b)(4).

Manufacturer Narrative

It was incorrectly reported that a non-conformance was found during the device history record review.There was no related non-conformance found.

Manufacturer Narrative

The investigation of this vamp jr kit concluded that a potential root cause could be related to an incorrect solvent bonding execution during the assembly process.Personnel acknowledgement was conducted at the manufacturing site to prevent recurrence of this type of complaint.

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: 8441814
• MDR Text Key: 139815655
• Report Number: 2015691-2019-00977
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• PMA/PMN Number: K925638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2019
• Device Model Number: PXVJ356
• Device Catalogue Number: PXVJ356
• Device Lot Number: 61547365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1