MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE TUOHY NEEDLE; EPIDURAL NEEDLE

Model Number	1150-6K091
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event took place in (b)(6) and has been reported through (b)(6) distribution subsidiary pajunk medical produkte gmbh.Currently the data is poor and the device has not been returned/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.
Event or Problem Description
Irn#: (b)(4).Broken hub.
Event or Problem Description
Irn#: (b)(4).Broken hub.
Additional Manufacturer Narrative
No failure product but pictures of the failure product were sent in for examination.The manufacturing documentation and the manufacturing specifications of the batch concerned were examined and did not allow any negative conclusions to be drawn.The facts of the case were examined.Result: the defect could be traced.The luer connection of the cannula hub has separated from the rest of the hub.This could be confirmed by examination of the pictures sent in by the customer.When examining a retention sample of the article from the corresponding batch, no deviations could be found.The luer connection could not be separated from the lor syringe even by strong force after connecting the syringe.The cause of the error cannot be determined beyond doubt without examining the product.We are not aware of any other complaints with this defect pattern at present.It is possibly a single product error.Based on clinical evaluation report and risk management file this file is considered as closed unless further information becomes available.

• Brand Name: TUOHY NEEDLE
• Common Device Name: EPIDURAL NEEDLE
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 10374695
• Report Number: 9611612-2020-00009
• Device Sequence Number: 3120464
• Product Code: BSP
• UDI-Device Identifier: 14048223004019
• UDI-Public: 14048223004019
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K040965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/09/2025
• Device Model Number: 1150-6K091
• Device Catalogue Number: 1150-6K091
• Device Lot Number: 1353.10
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other