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

Model Number 1150-6K091

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/09/2020

Event Type  malfunction  

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 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 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.

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
• Type of Device: ANAESTHESIA NEEDLE, EPIDURAL
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 10073554
• MDR Text Key: 207803353
• Report Number: 9611612-2020-00004
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 14048223004019
• UDI-Public: 14048223004019
• Combination Product (y/n): N
• PMA/PMN Number: K040965
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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 Manufacturer Received: 05/11/2020
• Initial Date FDA Received: 05/20/2020
• Supplement Dates Manufacturer Received: 05/11/2020
• Supplement Dates FDA Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other