MAUDE Adverse Event Report: COVIDIEN P400 PREM U/M 16FR CATH SECURE; DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE

Model Number	P4P16SD
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	10/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that it is unknown if the device will be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
Customer reports: a patient's foley disconnected and subsequently contracted a uti.
Additional Manufacturer Narrative
A device history record could not be reviewed because the lot number was reported as unknown.The sample was not provided for evaluation therefore the reported condition could not be confirmed.The root cause and corrective action plan for a detached catheter will be documented through a formal corrective/preventative action which has been initiated to address the reported condition to mitigate any further occurrences.This action is currently ongoing.This complaint will be closed with no further action and will be used for tracking and trending purposes.

• Brand Name: P400 PREM U/M 16FR CATH SECURE
• Common Device Name: DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 10648541
• Report Number: 9612030-2020-02652
• Device Sequence Number: 4044243
• Product Code: FFG
• UDI-Device Identifier: 20884521029597
• UDI-Public: 20884521029597
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020

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: P4P16SD
• Device Catalogue Number: P4P16SD
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 12/03/2020
• Patient Sequence Number: 1