MAUDE Adverse Event Report: PAJUNK GMBH MEDIZIINTECHNOLOGIE SPROTTE NRFIT; SPINAL NEEDLE, SINGLE USE, PRODUCT CODE: BSP

Model Number 021163-29A

Device Problem Device Handling Problem (3265)

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

Event Date 02/28/2023

Event Type  malfunction  

Event Description

Irn# (b)(4).Subject was brought to sedation unit for ip/sham procedure.Pharmacy provided sponsor's nrfit needles to be used per protocol for this procedure, which were different than those used on the previous study patient for the same procedure.Site was identified by palpation and sterilized.The patient was sedated and first attempt at csf collection was performed after sedation was assured.Upon first attempt using the provided nrfit lp 22 g needle, the provider was unable to access the intrathecal space due to the introducer length and inflexibility.The second attempt was made using the 25 g nrfit needle set and again, provider was unable to access the intrathecal space using this spinal needle set.Blood was returning and the concern was that repeated attempts with nrfit needles would result in potential for epidural hematoma.There were concerns that the nrfit needles would not appropriately access the intrathecal space.The procedure was continued with commercial/standard lp needle 22g x 1.5 in.The intrathecal space was accessed easily with standard needle and 3 cc of csf was collected for processing.Oav101b12301 ip was prepped to connect to the needle set for injection but it was found that the connector was not compatible with the hub of the standard commercial spinal needle.In order for procedure to continue, nrfit introducer was connected into the hub of the standard lp needle to push medication through the two needles and into the intrathecal space.In doing so, approximately 0.5 - 1 ml of fluid (csf and/or study drug) leaked out of the hub of the spinal needle and the rest entered the intrathecal space appropriately.The patient was cleaned, sedation lifted and the rest of study protocol completed.No adverse event was associated with the procedure.

Manufacturer Narrative

Currently the available data is poor.Investigation is still running.As soon as further information becomes available a follow up report will be sent in to the agency.

Manufacturer Narrative

Event took place in usa.Based on analysis, risk assessment, risk profile and clinical monitoring this file is considered as closed.In case new information becomes available a follow up report will be sent to the agency.Supplement: the initial report ran via cfn-based-no.9611612-2023-00003.In comparison to the initial report, data corrections were made in this final report due to new findings.Based on risk assessment and clinical assessment this file is considered as closed.Follow up / final report has been delayed due to technical problems.

Event Description

Irn# (b)(4).Subject was brought to sedation unit for ip/sham procedure.Pharmacy provided sponsor's nrfit needles to be used per protocol for this procedure, which were different than those used on the previous study patient for the same procedure.Site was identified by palpation and sterilized.The patient was sedated and first attempt at csf collection was performed after sedation was assured.Upon first attempt using the provided nrfit lp 22 g needle, the provider was unable to access the intrathecal space due to the introducer length and inflexibility.The second attempt was made using the 25 g nrfit needle set and again, provider was unable to access the intrathecal space using this spinal needle set.Blood was returning and the concern was that repeated attempts with nrfit needles would result in potential for epidural hematoma.There were concerns that the nrfit needles would not appropriately access the intrathecal space.The procedure was continued with commercial/standard lp needle 22g x 1.5 in.The intrathecal space was accessed easily with standard needle and 3 cc of csf was collected for processing.(b)(4) was prepped to connect to the needle set for injection but it was found that the connector was not compatible with the hub of the standard commercial spinal needle.In order for procedure to continue, nrfit introducer was connected into the hub of the standard lp needle to push medication through the two needles and into the intrathecal space.In doing so, approximately 0.5 - 1 ml of fluid (csf and/or study drug) leaked out of the hub of the spinal needle and the rest entered the intrathecal space appropriately.The patient was cleaned, sedation lifted and the rest of study protocol completed.No adverse event was associated with the procedure.

• Brand Name: SPROTTE NRFIT
• Type of Device: SPINAL NEEDLE, SINGLE USE, PRODUCT CODE: BSP
• Manufacturer (Section D): PAJUNK GMBH MEDIZIINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str.7; geisingen 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall str. 1; tuttlinger str. 7; geisingen 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; tuttlinger str. 7; geisingen 78187 ; 0499291586
• MDR Report Key: 16866123
• MDR Text Key: 314536558
• Report Number: 9611612-2023-00003
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 04048223114803
• UDI-Public: 04048223114803
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 021163-29A
• Device Catalogue Number: 021163-29A
• Device Lot Number: 1457
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2023
• 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