MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE EPILONG II; EPILONG II TUOHY_EPIDURAL ANESTHESIA KIT

Model Number	033115201-51
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Irn# (b)(4) incident occurred in italy: text from the first complaint with insufficient description: accidental dural puncture with a device that has shown, after use, a welding defect, this defect has been observed in other devices with the same lot.Of the patient we know has had a worsening of health status and prolonged illness after hospital discharge.Pajunk was asked to describe the incident and the product defect in more detail / result: on (b)(6) 2024, pajunk gmbh receives the information via movi that, the subject of the official report was less serious than expected and the actual needle defect was also badly described.Problem is that there is a leakage in the plastic hub of the tuohy ii".Note: rejected sample will be delivered on 2024-12-03.
Additional Manufacturer Narrative
Complaint took place in italy.All codes must be filled in for the initial report, although the initial report did not previously require the b, c and d codes.Otherwise the packing of the parcels will not work.In the subsequent fu1 with the determined test results, these can change again! the failure mode was only sent to us on 2024-12-03 and is currently still being checked - error analysis.The current processing status does not yet contain the complete analysis and test results, which will only be transmitted with the subsequent fu1.
Additional Manufacturer Narrative
Complaint took place in italy.Placeholders were inserted under point h6, codes b, c and d, which were not verified, as the initial report could only be packaged in this form if they were filled in.In this final report, these placeholders from the first report were changed after the root cause analysis.This concerns codes b, c and d.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.
Event or Problem Description
Irn# (b)(4) incident occurred in italy: text from the first complaint with insufficient description: accidental dural puncture with a device that has shown, after use, a welding defect, this defect has been observed in other devices with the same lot.Of the patient we know has had a worsening of health status and prolonged illness after hospital discharge.Pajunk was asked to describe the incident and the product defect in more detail / result: on (b)(6) 2024, pajunk gmbh receives the information via movi that, the subject of the official report was less serious than expected and the actual needle defect was also badly described.Problem is that there is a leakage in the plastic hub of the tuohy ii".Note: rejected sample will be delivered on (b)(6) 2024.

• Brand Name: EPILONG II
• Common Device Name: EPILONG II TUOHY_EPIDURAL ANESTHESIA KIT
• 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: 20892442
• Report Number: 9611612-2024-00033
• Device Sequence Number: 21093147
• Product Code: OGE
• UDI-Device Identifier: 04048223119501
• UDI-Public: 04048223119501
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K060311
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2024

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
• Operator of Device: Health Professional
• Device Model Number: 033115201-51
• Device Catalogue Number: 033115201-51
• Device Lot Number: 1548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 34 YR
• Patient Sex: Unknown