MAUDE Adverse Event Report: COVIDIEN P400 PREM U/M 14FR TMP SNS CSD; DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE

Model Number	P4P14TSD
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not 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
The customer reported that the foley catheter disconnected from the tamper resistance seal while the patient was sleeping in bed.There was no patient harm.
Additional Manufacturer Narrative
A review of the device history record could not be conducted because a lot number was not provided.No samples or digital images were received for evaluation therefore the reported condition could not be confirmed.Based on similarly reported cases, the root cause and action plan 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 14FR TMP SNS CSD
• 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: 10689870
• Report Number: 9612030-2020-02662
• Device Sequence Number: 3933404
• Product Code: FFG
• UDI-Device Identifier: 10884521066953
• UDI-Public: 10884521066953
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/03/2020

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: P4P14TSD
• Device Catalogue Number: P4P14TSD
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 12/03/2020
• Patient Sequence Number: 1