MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE NRFIT; ANAESTHESIA CONDUCTION NEEDLE, SPINAL, SINGLE DHOT

Model Number 121167-30A

Device Problems Bent (1059); Manufacturing, Packaging or Shipping Problem (2975); Device Handling Problem (3265)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2018

Event Type  malfunction  

Manufacturer Narrative

Event took place in the (b)(6) and has been reported through (b)(4).Currently, the data is poor and the device has not been sent back/ analysed.As soon as further data will be available, a follow up report will be sent in to the agency.

Event Description

(b)(4).Initial reporter´s narrative: on receipt the needles were found to be bent between hub and introducer making the use/control of the needle direction impossible, they were put aside and not used.

Manufacturer Narrative

Based on risk assessment and clinical evaluation file is considered as closed.(b)(4).

Event Description

Irn# (b)(4).Initial reporter´s narrative: on receipt the needles were found to be bent between hub and introducer making the use/control of the needle impossible, they were put aside and not used.

• Brand Name: SPROTTE NRFIT
• Type of Device: ANAESTHESIA CONDUCTION NEEDLE, SPINAL, SINGLE DHOT
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; tuttlinger str. 7; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 7204921
• MDR Text Key: 98056867
• Report Number: 9611612-2018-00009
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 14048223029821
• UDI-Public: 14048223029821
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K160294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/01/2022
• Device Model Number: 121167-30A
• Device Catalogue Number: 001163-30A
• Device Lot Number: 1223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other