MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE E-CATH® TSUI®; E-CATH® TSUI®_PERIPHERAL ANAESTHESIA CATHETER SET

Model Number	CA050008
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event took place in canada.Based on analysis, risk assessment, risk profile and clinical monitoring this file is considered as closed.In case new information becomes available a follow up report will be sent to the agency.This product analysis was carried out on the basis of all the information provided and the internal review at pajunk.Based on analysis, risk assessment, risk profile and clinical monitoringthis file is considered as closed.In case new information becomes available a follow up report will be sent to the agency.
Event or Problem Description
(b)(4).Integrity of catheter defective, detected once inserted in patient.Catheter leaking.After a picture of the affected product was sent, it was possible to recognise that the indwelling cannula has been complainted about.
Event or Problem Description
Irn#: (b)((4).Integrity of catheter defective, detected once inserted in patient.Catheter leaking.After a picture of the affected product was sent, it was possible to recognise that the indwelling cannula has been complainted about.
Additional Manufacturer Narrative
Event took place in canada.Based on analysis, risk assessment, risk profile and clinical monitoring this file is considered as closed.In case new information becomes available a follow up report will be sent to the agency.This product analysis was carried out on the basis of all the information provided and the internal review at pajunk.Based on analysis, risk assessment, risk profile and clinical monitoringthis file is considered as closed.In case new information becomes available a follow up report will be sent to the agency.

• Brand Name: E-CATH® TSUI®
• Common Device Name: E-CATH® TSUI®_PERIPHERAL ANAESTHESIA CATHETER SET
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str.; geisingen, 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall str. 1; tuttlinger str.; geisingen, 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; tuttlinger str.; geisingen, 78187 ; GM 78187 ; 0499291586
• MDR Report Key: 19679822
• Report Number: 9611612-2024-00005
• Device Sequence Number: 6964850
• Product Code: CAZ
• UDI-Device Identifier: 04048223116487
• UDI-Public: 04048223116487
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K152952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: CA050008
• Device Catalogue Number: 211185-40E
• Device Lot Number: 1471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown