MAUDE Adverse Event Report: GYRUS ACMI, INC. VACURETTE CURVED 14MM 10/PK; SYSTEM, ABORTION, VACUUM

Model Number	21593A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon requested 10mm curved vacurette cannula.The appropriate size per packaging was selected and opened.Upon inspection, it seemed too large.Further inspection of the packaging revealed that the wrong size indicator had been placed inside the packaging by the manufacturer.The actual size of the cannula was 14mm.A size 10mm cannula was then opened and used for the procedure.Per the circulator, the package insert stating size and what she reads to choose requested size shows the size as 10mm.The outer packaging states the size as 14mm.She reported that the ink color for the insert is red for the 10mm and 14mm.She suggested to have a different color for each size cannula for better visualization and ease in obtaining the desired size.The size on the outer packaging is also difficult to find and writing is very small.Current inventory was assessed and this one cannula being reported was the only found with incorrect packaging.Curved vacurette cannula and packaging (inner and outer) saved for quality.

• Brand Name: VACURETTE CURVED 14MM 10/PK
• Common Device Name: SYSTEM, ABORTION, VACUUM
• Manufacturer (Section D): GYRUS ACMI, INC.; 93 north pleasant st.; norwalk OH 44857
• MDR Report Key: 9368754
• Report Number: 9368754
• Device Sequence Number: 11497158
• Product Code: HHI
• UDI-Device Identifier: 00821925038004
• UDI-Public: (01)00821925038004(17)211218(10)12184476
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2019
• Report Date (Section F): 11/01/2019

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: 21593A
• Device Lot Number: 12184476
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/25/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 52
• Date Report Sent to FDA: 11/01/2019