MAUDE Adverse Event Report: COOK INC SPHERE INFLATION DEVICE

Catalog Number CID-20-30

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2021

Event Type  malfunction  

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 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.

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 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
• MDR Text Key: 243541509
• Report Number: 1820334-2021-01004
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 10827002310275
• UDI-Public: (01)10827002310275(17)231031(10)96271A003
• Combination Product (y/n): N
• PMA/PMN Number: K953522
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 03/24/2021
• Supplement Dates Manufacturer Received: 05/03/2021
• Supplement Dates FDA Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1