MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE E-KATHETER II SET TSUI; E-KATHETER II SET TSUI_CATHETER, CONDUCTION, ANESTHETIC

Model Number	AA610027
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Irn#(b)(4).Complaint took place in usa.Under item h6, codes b, c and d, placeholders have been inserted that have not been verified, as the intial report can only be packed in this form if these are filled in, although no analysis has yet taken place.These b, c and d codes can only be transmitted correctly in the subsequent message as the analysis is still being processed.You will receive the complete report with all test results in the subsequent message.
Event or Problem Description
Irn# (b)(4).Incident occurred in usa: with needle inserted, upon injecting medication, the "hub" sprung leak.There was a "fountain" of medication squirting from the hub while under pressure.Tried another needle and the same event occured.Tried a different pkg., different lot#- all ok.
Event or Problem Description
Irn # (b)(4).Incident occurred in usa: with needle inserted, upon injecting medication, the "hub" sprung leak.There was a "fountain" of medication squirting from the hub while under pressure.Tried another needle and the same event occured.Tried a different pkg., different lot#- all ok.
Additional Manufacturer Narrative
Irn # (b)(4).Complaint took place in usa.Based on risk assessment and clinical assessment this file is considered as closed.In case new information becomes available a follow up report will be sent to the agency.

• Brand Name: E-KATHETER II SET TSUI
• Common Device Name: E-KATHETER II SET TSUI_CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 21383088
• Report Number: 9611612-2025-00004
• Device Sequence Number: 8388376
• Product Code: BSO
• UDI-Device Identifier: 04048223121931
• UDI-Public: 04048223121931
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2025

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
• Operator of Device: Health Professional
• Device Model Number: AA610027
• Device Catalogue Number: 311285-40E
• Device Lot Number: 1562
• 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: 02/07/2025
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 02/14/2025
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown