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

Model Number	1150-6K091
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2020
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 (b)(4).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).Tentative translation of initial reporter´s narrative: when the cannula was removed, the complete hub came off.The cannula tube had to be removed with a needle holder.
Event or Problem Description
Irn#: (b)(4).Tentative translation of initial reporter´s narrative: when the cannula was removed, the complete hub came off.The cannula tube had to be removed with a needle holder.
Additional Manufacturer Narrative
Event took place in germany and has been reported through german distribution subsidiary pajunk medical produkte gmbh.Based on risk assessment and clinical assessment case is considered as closed.

• Brand Name: TUOHY NEEDLE
• Common Device Name: ANAESTHESIA NEEDLE, EPIDURAL
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 10073554
• Report Number: 9611612-2020-00004
• Device Sequence Number: 11469832
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2020

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: 12/18/2024
• Device Model Number: 1150-6K091
• Device Catalogue Number: 001151-1004
• Device Lot Number: 1330.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 07/23/2020
• 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