MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE EPISPIN LOCK; EPISPIN LOCK_SPINAL-EPIDURAL ANAESTHESIA KIT

Model Number	0021351-30
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Codes	Abrasion (1689); Needle Stick/Puncture (2462)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event took place in france.The facts of the case, relevant tests are currently in process.In case new information becomes available a follow up report will be sent to the agency.
Event or Problem Description
Irn# (b)(4).Avant l'utilisation du trocart de péridurale sur le patient, le médecin se pique avec l'aiguille.Il semblerait que la protection soit trop courte : l'aiguille est non protégée.Before using the epidural trocar on the patient, the doctor pricks himself with the needle.It seems that the protection is too short: the needle is unprotected.
Additional Manufacturer Narrative
Event took place in france.The facts of the case, relevant tests are currently in process.In case new information becomes available a follow up report will be sent to the agency.
Event or Problem Description
Irn# (b)(4).Avant l'utilisation du trocart de péridurale sur le patient, le médecin se pique avec l'aiguille.Il semblerait que la protection soit trop courte : l'aiguille est non protégée.Before using the epidural trocar on the patient, the doctor pricks himself with the needle.It seems that the protection is too short: the needle is unprotected.
Event or Problem Description
Irn# (b)(4).Avant l'utilisation du trocart de péridurale sur le patient, le médecin se pique avec l'aiguille.Il semblerait que la protection soit trop courte : l'aiguille est non protégée.Before using the epidural trocar on the patient, the doctor pricks himself with the needle.It seems that the protection is too short: the needle is unprotected.
Additional Manufacturer Narrative
Event took place in france.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.This product analysis was carried out on the basis of all the information provided and the internal review at pajunk.Based on analysis, risk assessment, risk profile and clinical monitoringthis file is considered as closed.In case new information becomes available a follow up report will be sent to the agency.
Event or Problem Description
Irn#: (b)(4).Event took place in france: avant l'utilisation du trocart de péridurale sur le patient, le médecin se pique avec l'aiguille.Il semblerait que la protection soit trop courte : l'aiguille est non protégée.Before using the epidural trocar on the patient, the doctor pricks himself with the needle.It seems that the protection is too short: the needle is unprotected.
Additional Manufacturer Narrative
Event took place in france.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.This product analysis was carried out on the basis of all the information provided and the internal review at pajunk.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.

• Brand Name: EPISPIN LOCK
• Common Device Name: EPISPIN LOCK_SPINAL-EPIDURAL ANAESTHESIA KIT
• 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: 19739109
• Report Number: 9611612-2024-00012
• Device Sequence Number: 19743167
• Product Code: OFT
• UDI-Device Identifier: 04048223103647
• UDI-Public: 04048223103647
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K060563
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/06/2024

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
• Device Model Number: 0021351-30
• Device Catalogue Number: 0021351-30
• Device Lot Number: 1538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Supplement Date Received by Manufacturer: 07/10/2024; 07/10/2024; 07/10/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 07/15/2024; 07/17/2024; 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown