MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE EPILONG NRFIT®; EPILONG NRFIT®_EPIDURAL ANAESTHESIA KIT

Model Number	0331166-51
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event took place in united kingdom.The first reporter with contact details of the healthcare institution was not transmitted.The contact details have been requested on 09/13/2024.The product analysis has been in progress since the initial notice dated 09/13/2024 and will be published with the test results in the follow-up report.
Event or Problem Description
Irn# (b)(6).During an epidural insertion for labour analgesia the hub of the needle sheared off with no undue force having been applied resulting in the metal needle being left in the patient's back.Fortunately i was able to get hold of the end of it, just, and remove it from the patient.
Additional Manufacturer Narrative
Event took place in (b)(6).Based on clinical assessment and risk assessment this case 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 uk: during an epidural insertion for labour analgesia the hub of the needle sheared off with no undue force having been applied resulting in the metal needle being left in the patient's back.Fortunately, i was able to get hold of the end of it, just, and remove it from the patient.

• Brand Name: EPILONG NRFIT®
• Common Device Name: EPILONG NRFIT®_EPIDURAL ANAESTHESIA KIT
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 20234323
• Report Number: 9611612-2024-00020
• Device Sequence Number: 8162925
• Product Code: CAZ
• UDI-Device Identifier: 04048223053218
• UDI-Public: 04048223053218
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2024

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: 0331166-51
• Device Catalogue Number: 0331166-51
• Device Lot Number: 1460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2022
• 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; Other
• Patient Age: 28 YR
• Patient Sex: Unknown
• Patient Weight: 126 KG