MAUDE Adverse Event Report: COVIDIEN CURITY MONO-FLO 14FR WO PVPI; COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Model Number	6162MF
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported when putting water into the balloon, the water was difficult to get in and out and the balloon would not deflate.
Additional Manufacturer Narrative
A device history record could not be reviewed because the lot number was reported as unknown.One unused sample was received for evaluation.A visual inspection of the device was completed according to procedures however the visual and functional evaluation of the reported condition could not be confirmed on the returned device.The root cause and corrective actions could not be identified.There is no corrective action plan required since the sample is within specification.We will continue monitoring the process for any adverse trends that require immediate attention.

• Brand Name: CURITY MONO-FLO 14FR WO PVPI
• Common Device Name: COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 10684725
• Report Number: 9612030-2020-02660
• Device Sequence Number: 571878
• Product Code: KNX
• UDI-Device Identifier: 10884521050587
• UDI-Public: 10884521050587
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020

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: No Information
• Device Model Number: 6162MF
• Device Catalogue Number: 6162MF
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 12/03/2020
• Patient Sequence Number: 1