MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE EPISPIN LOCK; EPISPIN LOCK_COMBINED EPIDURAL AND SPINAL ANAESTHESIA NEEDLES AND KITS

Model Number	001151-37A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This incident took place in italy.This case is considered as closed.If further information becomes available an update will be sent to the agency.
Event or Problem Description
(b)(4).This incident took place in italy.Device used for epidural analgesia during labor.Upon removal, there was an unexpected breakage of the tip approximately 11 cm from the end.A surgical procedure was performed to remove the terminal portion.

• Brand Name: EPISPIN LOCK
• Common Device Name: EPISPIN LOCK_COMBINED EPIDURAL AND SPINAL ANAESTHESIA NEEDLES AND KITS
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, 78187 ; GM 78187
• Manufacturer Contact: armin pfeifer ; karl-hall-str. 1; geisingen 78187 ; 0497704929
• MDR Report Key: 24764172
• Report Number: 9611612-2026-00005
• Device Sequence Number: 13336943
• Product Code: CAZ
• UDI-Device Identifier: 04048223133125
• UDI-Public: 04048223133125
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/02/2026

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
• Operator of Device: Health Professional
• Device Model Number: 001151-37A
• Device Catalogue Number: 0021351-18
• Device Lot Number: 1550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2024
• 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 Age: 36 YR
• Patient Sex: Unknown