MAUDE Adverse Event Report: SECHRIST INDUSTRIES INC. SECHRIST INDUSTRIES INC.; MIXER, GENERAL, GERMAN

Model Number	3500CP-G4
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Issue discovered during pm service by third party.Customer did not report issue to our eu distributor.No patient involvement or injury reported.Neither customer or distributor reported to fda according to the information we have at this time.Device in question will not be evaluated by sechrist as distributor will evaluate.At this time, the report is based on the information we have.We have requested more information from our distributor in regard to service records and disposition of the device in question.Manufacturer reference file no.(b)(4).
Event or Problem Description
During pm service by a third party, the mixer was discovered to be contaminated with blood on the inside and therefore determined to be defective.No patient injury reported.

• Brand Name: SECHRIST INDUSTRIES INC.
• Common Device Name: MIXER, GENERAL, GERMAN
• Manufacturer (Section D): SECHRIST INDUSTRIES INC.; 4225 e. la palma avenue; anaheim CA 92807
• Manufacturer (Section G): SECHRIST INDUSTRIES INC.; 4225 e. la palma avenue; anaheim CA 92807
• Manufacturer Contact: majid mashayekh ; 4225 e. la palma avenue; anaheim, CA 92807 ; 7145798400
• MDR Report Key: 20904359
• Report Number: 2020676-2024-00022
• Device Sequence Number: 18430792
• Product Code: BZR
• UDI-Device Identifier: 00899660002796
• UDI-Public: 00899660002796
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K992503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2024

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
• Operator of Device: Health Professional
• Device Model Number: 3500CP-G4
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown