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

Model Number 120066-30A

Device Problems Crack (1135); Fluid/Blood Leak (1250); Nonstandard Device (1420)

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

Event Date 01/03/2018

Event Type  malfunction  

Manufacturer Narrative

Event took place in the (b)(6) and has been reported through (b)(6) distribution subsidiary pajunk medical ltd.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: 24g x 90mm sprotte nrfit introduced to subarachnoid space, on injection immediately leaked from side of hub, tried twice with same very obvious result.Needle removed and replaced for use with successful competition.

Manufacturer Narrative

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

Event Description

Irn# (b)(4).From initial reporter´s narrative: 24g x 90mm sprotte® nrfit introduced to subarachnoid space, on injection immediately leaked from side of hub, tried twice with same very obvious result.Needle removed and replaced for use with successful competition.

• Brand Name: SPROTTE NRFIT
• Type of Device: ANAESTHESIA CONDUCTION NEEDLE, SPINAL, SINGLE SHOT
• 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: 7204922
• MDR Text Key: 97801946
• Report Number: 9611612-2018-00006
• 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: 07/03/2022
• Device Model Number: 120066-30A
• Device Catalogue Number: 001163-30A
• Device Lot Number: 1213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2017
• 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; Required Intervention