MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE NRFIT; SPINAL NEEDLE, SINGLE USE

Model Number 121163-30A

Device Problems Nonstandard Device (1420); Material Deformation (2976); No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

13 originally packed sprotte® nrfit 121163-30a were submitted, unfortunately the actual failure product is not available.The manufacturing documentation and the manufacturing specifications of the affected batch were checked and did not allow any adverse conclusions.The submitted products were examined.Result: all 13 submitted sprotte® nrfit cannulas made of lot 1342 were examined.All cannulas were found to be free of burrs, the cannula windows and the cannula surface as well as the mandrins of the cannulas.The mandrins of the sprotte cannulas could be removed without any abnormalities, scratching when pulling them out could not be traced.Deformations of the cannula, stylet or introducer were not visible.We assume that the cannula was subjected to a force during use due to a local cause and that it was deformed in the process (see warning note for puncture in the instructions for use).The cannula corresponds to the specifications, no material deviation could be detected.The deformations described indicate that the cannula tube has been overstressed.Our sprotte® cannulas meet the requirements of the applicable standard din en iso 9626 regarding bending stiffness and breaking strength.The deformed sprotte® nrfit cannula could be removed, the patient is doing well according to the customer experience report.We do not have any further complaints with this defect pattern for this product.This is a known, procedure-specific complication in spinal anesthesia.With the available data a product defect cannot be confirmed.Note: please always submit the actual failure product for analysis, since a described failure image can be best understood and analyzed here.Based on risk management files and clinical evaluation report this file is considered as closed unless further information becomes available.

Event Description

(b)(4).Category one lscs, spinal anaesthetic.Clinically straightforward spinal anaesthetic, no difficulty obtaining clinical end point of spinal needle insertion.On removing centre portion of spinal needle it felt very gratey, it was not smooth as you would expect.No csf, seen from needle, which was surprising as clinically i felt i was in the correct place.Switched to new needle, which i inserted through same introducer with no other adjustments.Centre part removed smoothly as you would expect and free flowing csf was seen.Spinal anaesthetic successfully.On examining the first needle after the event it appeared bent.The exact same thing happened to me on (b)(6) 2020, with a gratey sensation on removing centre portion of needle, no csf despite good clinical end point, needle appeared bent on removal despite non difficult insertion.The lot numbers (1324) etc are identical on both needles but the hub on the gratey one was a paler purple.On examining the selection of needles there was a mixture of ones with a pale and darker purple hub all with identical lot numbers.On opening another pale purple hubbed needle, again the centre bit was gratey to remove, not smooth as it should be, and appeared slightly bent.Needle bent after puncture.No liquor received.Needle gratey and not smooth.13 originally packed sprotte® nrfit 121163-30a were submitted, unfortunately the actual failure product is not available.The manufacturing documentation and the manufacturing specifications of the affected batch were checked and did not allow any adverse conclusions.The submitted products were examined.Result: all 13 submitted sprotte® nrfit cannulas made of lot 1342 were examined.All cannulas were found to be free of burrs, the cannula windows and the cannula surface as well as the mandrins of the cannulas.The mandrins of the sprotte cannulas could be removed without any abnormalities, scratching when pulling them out could not be traced.Deformations of the cannula, stylet or introducer were not visible.We assume that the cannula was subjected to a force during use due to a local cause and that it was deformed in the process (see warning note for puncture in the instructions for use).The cannula corresponds to the specifications, no material deviation could be detected.The deformations described indicate that the cannula tube has been overstressed.Our sprotte® cannulas meet the requirements of the applicable standard din en iso 9626 regarding bending stiffness and breaking strength.The deformed sprotte® nrfit cannula could be removed, the patient is doing well according to the customer experience report.We do not have any further complaints with this defect pattern for this product.This is a known, procedure-specific complication in spinal anesthesia.With the available data a product defect cannot be confirmed.Note: please always submit the actual failure product for analysis, since a described failure image can be best understood and analyzed here.

• Brand Name: SPROTTE NRFIT
• Type of Device: SPINAL NEEDLE, SINGLE USE
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 10964104
• MDR Text Key: 269558175
• Report Number: 9611612-2020-00014
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 14048223026905
• UDI-Public: 14048223026905
• 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: distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 121163-30A
• Device Catalogue Number: 121163-30A
• Device Lot Number: 1324
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2019
• 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): Required Intervention