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

Model Number 321151-31A

Device Problems Sticking (1597); Device Issue (2379); Incorrect Device Or Component Shipped (2962); Mechanical Jam (2983)

Patient Problem Awareness during Anaesthesia (1707)

Event Type  malfunction  

Manufacturer Narrative

Event took place in (b)(6); date of event unknown; follow up report will be sent into agency once investigations are finished.

Event Description

(b)(4).Tentative summarizing translation from user's narrative: stylet could not be removed from spinal needle.Had to be replaced and repunctured.

Manufacturer Narrative

Event took place in (b)(6); date of event unknown.File is considered as closed.

Event Description

(b)(4).Date of event is still unknown.Tentative summarizing translation from user's narrative: unable to advance needle through introducer.

• Brand Name: SPROTTE
• Type of Device: ANAESTHESIA CONDUCTION NEEDLE, SPINAL
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; regulatory & safety affairs; geisingen, baden-wuerttemberg 78187 ; GM 78187 ; 7704929158
• MDR Report Key: 5549661
• MDR Text Key: 42543798
• Report Number: 9611612-2016-00037
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K911260
• 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: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/01/2021
• Device Model Number: 321151-31A
• Device Catalogue Number: 321151-31A
• Device Lot Number: 1145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• 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