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

Model Number 21593A

Device Problems Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/24/2019

Event Type  malfunction  

Event 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
• Type of Device: SYSTEM, ABORTION, VACUUM
• Manufacturer (Section D): GYRUS ACMI, INC.; 93 north pleasant st.; norwalk OH 44857
• MDR Report Key: 9368754
• MDR Text Key: 167808061
• Report Number: 9368754
• Device Sequence Number: 1
• Product Code: HHI
• UDI-Device Identifier: 00821925038004
• UDI-Public: (01)00821925038004(17)211218(10)12184476
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/01/2019,10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21593A
• Device Lot Number: 12184476
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/01/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 10950 DA
• Patient Weight: 52