MAUDE Adverse Event Report: COOK INC SPHERE INFLATION DEVICE

Catalog Number	CID-20-30
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Common device name: ptm;koe.Name and address: postal code: (b)(6).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, a sphere inflation device package was opened, and a foreign white substance was confirmed on the device.The user wiped it off with gauze and used the device to complete the procedure.There have been no adverse effects to the patient reported.
Additional Manufacturer Narrative
This report is being submitted as a correction.Upon further review, it has been determined that atrion is the labeled manufacturer of the complaint device and is therefore responsible for all regulatory reporting and complaint investigation requirements.The complaint information has been provided to the manufacturer (atrion) and entered in the complaint file by cook inc.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: SPHERE INFLATION DEVICE
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11564405
• Report Number: 1820334-2021-01004
• Device Sequence Number: 3291269
• Product Code: MAV
• UDI-Device Identifier: 10827002310275
• UDI-Public: (01)10827002310275(17)231031(10)96271A003
• Combination Product (Y/N): N
• PMA/510(K) Number: K953522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2021

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 Expiration Date: 10/31/2023
• Device Catalogue Number: CID-20-30
• Device Lot Number: 96271A003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1