MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE STANDARD; ANAESTHESIA CONDUCTION NEEDLE, SPINAL, SINGLE SHOT

Model Number	131151-30C
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Currently the data is poor and the device has not been sent back/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.
Event or Problem Description
(b)(4).Reporter´s narrative: epidural needle split in half with patient contact.Defective product is with pathology.
Event or Problem Description
Irn# (b)(4).Reporter´s narrative: epidural needle split in half with patient contact.Defective product is with pathology.
Additional Manufacturer Narrative
Based on risk assessment and clinical assessment file is considered as closed.

• Brand Name: SPROTTE STANDARD
• Common Device Name: ANAESTHESIA CONDUCTION NEEDLE, SPINAL, SINGLE SHOT
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 8761731
• Report Number: 9611612-2019-00017
• Device Sequence Number: 2523597
• Product Code: BSP
• UDI-Device Identifier: 14048223000707
• UDI-Public: 14048223000707
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K911202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2019

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 Model Number: 131151-30C
• Device Catalogue Number: 131151-30C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/05/2019
• Supplement Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 07/04/2019
• Supplement Report FDA Received Date: 12/13/2019
• 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: Other