MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE; SPINAL NEEDLE, SINGLE USE

Model Number	121151-27A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event took place in estonia and has been reported through estonian distributor.Currently the data is poor and the device has not been returned/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.
Event or Problem Description
Irn # (b)(4).Tentative summarizing translation of initial reporter´s narrative: we received today complaint regarding sprotte needle re.121151-27a, lot 1323.After drug administration to the spinal canal, the needle hub separated from the needle it gut stuck in the patient's spine.Doctor pulled the needle out with forceps.Event happened today (b)(6) 2020.Patient is safe an unharmed.
Event or Problem Description
Irn # (b)(4).Tentative summarizing translation of initial reporter´s narrtive: we received todad complaint regarding sprotte needle re.121151-27a, lot 1323.After drug administration to the spinal canal, the needle hub separated from the needle it gut stuck inthe patient's spine.Doctor pulled the needle out with forceps.Event happened today (b)(6) 2020.Patient is safe an unharmed.
Additional Manufacturer Narrative
Event took place in estonia and has been reported through estonian distributor.Currently the data is poor and the device has not been returned/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.Neither a breakdown product nor pictures of the breakdown product were sent in for investigation.The manufacturing documentation and the manufacturing specifications of the batch concerned were examined and did not allow any unfavourable conclusions to be drawn.The facts of the case were examined.Result: the error could not be reconstructed.A retention pattern of the article from the batch concerned could unfortunately not be checked.We are not aware of any other complaints with this error pattern within this batch.Within our production processes, our cannulas are subject to random sample checks, which did not show any deviations within the respective batch.We cannot determine the cause of the error without examining the defective product.On the basis of the available data, this may be an single product error.Based on risk management file and clinical evaluation this file is considered as closed unless further information becomes available.

• Brand Name: SPROTTE
• Common Device Name: SPINAL NEEDLE, SINGLE USE
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 10506057
• Report Number: 9611612-2020-00012
• Device Sequence Number: 1328119
• Product Code: BSP
• UDI-Device Identifier: 14048223001438
• UDI-Public: 14048223001438
• Combination Product (Y/N): N
• PMA/510(K) Number: K911202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2020

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: Health Professional
• Device Expiration Date: 10/28/2024
• Device Model Number: 121151-27A
• Device Catalogue Number: 121151-27A
• Device Lot Number: 1323
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/07/2020
• Supplement Date Received by Manufacturer: 09/07/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 12/08/2020
• 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: Required Intervention