MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE®

Catalog Number	321151-31A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigations are ongoing.Final evaluation can be found in the following report.
Event or Problem Description
(b)(4).Incident occurred in germany.Tentative translation: it was not the cannula but the introducer that slipped out of the connector after use - the adhesive had come loose.The end of the introducer was still protruding from the patient, so the cannula could be removed with tweezers.No further treatment was necessary - the patient is doing well.
Additional Manufacturer Narrative
Irn# (b)(4).2026-01-30 update: device was evaluated and the imdrf codes adjusted.This case is considered as closed.If further information becomes available an update will be sent to the agency.
Event or Problem Description
Irn# (b)(4).Incident occurred in germany.Tentitive translation: it was not the cannula but the introducer that slipped out of the connector after use - the adhesive had come loose.The end of the introducer was still protruding from the patient, so the cannula could be removed with tweezers.No further treatment was necessary - the patient is doing well.

• Brand Name: SPROTTE®
• Common Device Name: SPROTTE®
• 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 ; GM 78187
• MDR Report Key: 23876578
• Report Number: 9611612-2025-00051
• Device Sequence Number: 17336142
• Product Code: BSP
• UDI-Device Identifier: 04048223128060
• UDI-Public: 04048223128060
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K911260
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 321151-31A
• Device Lot Number: 1569
• 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: Not provided
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• 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: Other
• Patient Sex: Unknown