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

Model Number 211163-29A

Device Problems Crack (1135); Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problems Inadequate Pain Relief (2388); Underdose (2542)

Event Date 04/20/2018

Event Type  malfunction  

Manufacturer Narrative

Event took place in the (b)(6) and has been reported through (b)(4) distribution subsidiary (b)(4).Currently the data is poor and the device has not been sent back/ analysed.As soon as further data will be available a follow up report will be sent into the agency.

Event Description

(b)(4).From initial reporter´s narrative: two x identical incidents (b)(6) 2018 and (b)(6) 2018: spinal anaesthesia to patients undergoing elective caesarean section.The spinal nrfit sprotte 25g needle was inserted and csf was aspirated appropriately.On injection of the spinal anaesthetic solution, leakage from the hub of the needle was noted.Potentially insufficient anaesthetic was injected into the patient.On close inspection of the 2 needles there was an identical pattern hairline crack in the hub of the needle.We have recently changed the design and procurement of our spinal needles, and switched to nrfit sprotte needles produced by pajunk.A cracked spinal needle has the potential to cause inadequate spinal anaesthesia leading to intraoperative pain and distress and an unanticipated general anaesthetic.

Manufacturer Narrative

Event took place in the uk and has been reported through british distribution subsidiary pajunk medical ltd.Based on risk management results and clinical file this file is considered as closed.Attachment: [complaint report for 153-18.Pdf].

Event Description

Irn# (b)(4).From initial reporter´s narrative: 2 x identical incidents (b)(6) 2018 and (b)(6) 2018: spinal anaesthesia to patients undergoing elective caesarean section.The spinal nrfit sprotte 25g needle was inserted and csf was aspirated appropriately.On injection of the spinal anaesthetic solution, leakage from the hub of the needle was noted.Potentially insufficient anaesthetic was injected into the patient.On close inspection of the 2 needles there was an identical pattern hairline crack in the hub of the needle.We have recently changed the design and procurement of our spinal needles, and switched to nrfit sprotte needles produced by pajunk.A cracked spinal needle has the potential to cause inadequate spinal anaesthesia leading to intraoperative pain and distress and an unanticipated general anaesthetic.

• 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. 07; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 7482185
• MDR Text Key: 107962752
• Report Number: 9611612-2018-00023
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 14048223030315
• UDI-Public: 14048223030315
• Combination Product (y/n): N
• PMA/PMN Number: K160294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 05/15/2022
• Device Model Number: 211163-29A
• Device Catalogue Number: 211163-29A
• Device Lot Number: 1206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other