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

Model Number 121166-30A

Device Problem Fluid/Blood Leak (1250)

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

Event Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

Event took place in the (b)(6) and has been reported through (b)(6) distribution subsidiary (b)(6) medical ltd.Device was not returned, but video sent.Based on risk assessment and clinical evaluation file is considered as closed.(b)(4).

Event Description

(b)(4).Needle leaking at the joint of hub and metal needle.

• Brand Name: SPROTTE NRFIT
• Type of Device: ANAESTHESIA CONDUCTING NEEDLE, SPINAL, SINGLE DHOT
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 07; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 07; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; tuttlinger str. 07; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 7654099
• MDR Text Key: 112849509
• Report Number: 9611612-2018-00028
• 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: K160295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/02/2023
• Device Model Number: 121166-30A
• Device Catalogue Number: 001163-30A
• Device Lot Number: 1213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2018
• 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