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

Model Number	211163-29A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); Underdose (2542)
Date of Event	04/20/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 9611612-2018-00023
• Device Sequence Number: 1314008
• Product Code: BSP
• UDI-Device Identifier: 14048223030315
• UDI-Public: 14048223030315
• 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,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2018

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?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 04/27/2018
• Supplement Date Received by Manufacturer: 04/27/2018
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 05/28/2018
• 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