MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE 2.G; SPINAL NEEDLE, SINGLE USE

Model Number	041251-29A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event took place in (b)(6) and has been reported through (b)(4).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).Summarizing tentative translation of initial reporter´s narrative ((b)(6)): defect break the needle after medication injection upon.Removal from patient.Fortunately able to remove needle with introducer in situ.[needle broke during use.Part remained in patient.Part was removed.].
Event or Problem Description
Irn #(b)(4).Summarizing tentative translation of initial reporter´s narrative (malaysia): defect break the needle after medication injection upon.Removal from patient.Fortunately able to remove needle with introducer in situ.[needle broke during use.Part remained in patient.Part was removed.].
Additional Manufacturer Narrative
Event took place in malaysia and has been reported through malaian distributor (b)(4).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.No failure product or pictures of the failure product 041251-29a/lot 1140 ( delivery:12/2015) were submitted.The manufacturing documentation and the manufacturing specifications of the batch concerned were checked and did not allow any unfavorable conclusions to be drawn.The matter was investigated.Result: the defect cannot be reproduced without failure product or pictures of the failure product.When examining three retention samples from the same lot 1140, no abnormalities or deviations were found.The cannulas meet the specifications.We are currently not aware of any other complaints with this error pattern for this article.After evaluating the available data, we assume that the error in the application was caused by a local cause.A product defect cannot be traced.Based on risk management file and clinical evaluation report this file is considered as closed unless further information becomes available.

• Brand Name: SPROTTE 2.G
• 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: 10506056
• Report Number: 9611612-2020-00011
• Device Sequence Number: 1270017
• Product Code: BSP
• UDI-Device Identifier: 14048223024291
• UDI-Public: 14048223024291
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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
• Initial Reporter Occupation: Risk Manager
• 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: 11/01/2020
• Device Model Number: 041251-29A
• Device Catalogue Number: 041251-29A
• Device Lot Number: 1140
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• 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