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

Model Number 001163-30A

Device Problems Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682); Device Handling Problem (3265)

Patient Problem Pain (1994)

Event Date 02/28/2018

Event Type  Injury  

Event Description

(b)(4).Dr (b)(6) was supervising dr (b)(6) using nrfit 24g x 90 sprotte spinal needle.Introducer was placed and spinal needle then inserted up to the hilt as patient was quite large (stated as obese).On attempting to remove the purple stylet to observe for csf, this could not be achieved so dr (b)(6) was advised to remove all parts and start again.On doing this the damage to the sprotte was noted and put aside.Another set was opened and used without incident.Another set from same lot number was opened and examined and damage couldn't be replicated by hand.Dr (b)(6) has isolated the damaged item and set aside for collection and will also salvage the packaging too.

• 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: 7372802
• MDR Text Key: 103528209
• Report Number: 9611612-2018-00022
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/20/2022
• Device Model Number: 001163-30A
• Device Catalogue Number: 001163-30A
• Device Lot Number: 1230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2017
• 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