MAUDE Adverse Event Report: BEAVER-VISITEC INTERNATIONAL, INC. VISITEC; VISCOFLOW CANNULA 27G

Model Number	585282
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that "contamination and missing expiry date has been identified within batch during incoming inspection.".

• Brand Name: VISITEC
• Common Device Name: VISCOFLOW CANNULA 27G
• Manufacturer (Section D): BEAVER-VISITEC INTERNATIONAL, INC.; 500 totten pond rd; 10 citypoint; waltham MA 02451
• Manufacturer (Section G): BEAVER-VISITEC INTERNATIONAL, INC.; 500 totten pond rd; 10 citypoint; waltham MA 02451
• Manufacturer Contact: aminah crawford ; 500 totten pond rd; 10 citypoint; waltham, MA 02451 ; 7815306377
• MDR Report Key: 16840391
• Report Number: 1211998-2023-00043
• Device Sequence Number: 7683939
• Product Code: HMX
• UDI-Device Identifier: 30886158003015
• UDI-Public: 30886158003015
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2023

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 Model Number: 585282
• Device Catalogue Number: 585282
• Device Lot Number: 6058608
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 04/28/2023
• Patient Sequence Number: 1
• Patient Sex: Unknown