MAUDE Adverse Event Report: PICCO CATHETER; PROBE, THERMODILUTION

Model Number	PV2014L16-A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The issue has been detected during in depth investigation of a returned picco catheter under complaint.Further information provided by the investigator of the device revealed that the crack is inside the channel separation.The catheters are 100% leak tested during production.Additionally, the ifu indicates to flush the catheter with saline solution prior to its use: "open the packaging, remove the catheter (1) and rinse the lumen with sterile saline solution (0.9% nacl) according to hospital regulations." no similar complaints have been received for this batch.A dhr check could not identify any non-conformities or deviations relevant to the reported issue.Overall, it can be concluded that there is no indication for a systematic root cause as a deficiency of design, production or material due to the very low complaint rate (< 0,01 %, considering all types of picco catheters).The root cause could not be traced to a deficiency of the device.The most probable root cause is seen in inappropriate handling with the device after use.Potential scenarios are an inappropriate handling during sample return shipment.This is supported by the information provided by the initial complainant that there was no leakage.Overall, investigations did no indicate that the device failed to meet its specification during use due to the detected crack.Upon the event occurrence the device was not used on a patient as the issue has been detected during product investigation.The issue is monitored on a regularly basis during the monthly complaint review and during post market surveillance activities in order to detect early trends.As there is no trend for this kind of issue, no additional actions will be taken.Based on this, the complaint will be closed.The report is considered as a combined initial and final report.
Event or Problem Description
During investigation of a returned picco catheter it was detected that there is a crack in the blue lumen tubing close to the channel separation.No harm or clinical consequences occurred to the patient.The device was not used on a patient when the issue has been detected.Leaking parts of the blue lumen tubing are regarded as an event that could lead to serious injury, if the malfunction were to recur.Manufacturer reference #:(b)(4).

• Brand Name: PICCO CATHETER
• Common Device Name: PROBE, THERMODILUTION
• MDR Report Key: 12511384
• Report Number: 3003263092-2021-00011
• Device Sequence Number: 1008637
• Product Code: KRB
• UDI-Device Identifier: 04250094500962
• UDI-Public: (01)04250094500962(17)240930(11)191016(10)676063
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K171620
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/22/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: PV2014L16-A
• Device Catalogue Number: 6885046
• Device Lot Number: 676063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 09/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 62