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

Model Number	001163-30A
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682); Device Handling Problem (3265)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/28/2018
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: 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
• MDR Report Key: 7372802
• Report Number: 9611612-2018-00022
• Device Sequence Number: 1161125
• Product Code: BSP
• UDI-Device Identifier: 14048223029821
• UDI-Public: 14048223029821
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other