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

Model Number	P4P16TSD
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 came disconnected from green seal on critically ill proned/paralyzed patient.The catheter was removed to be replaced.The proned patient was turned onto side to recath, requiring approximate of 15 minutes of intervention causing the patient to decompensate.Additional information received from the customer stated that the patient's position was changed to supine to insert the new foley.No treatment was required.The patient is recovering.
Additional Manufacturer Narrative
A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.Samples were not received for the investigation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported condition and determine the root cause.If samples are received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.As part of continuous improvements, a corrective and preventative action plan has been opened to address the reported condition through a more robust investigation.The results of the investigation will be documented through the capa.This complaint will be used for tracking and trending purposes.

• Brand Name: P400 PREM U/M 16FR 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: 11216641
• Report Number: 9612030-2021-02783
• Device Sequence Number: 17109090
• Product Code: FFG
• UDI-Device Identifier: 10884521066960
• UDI-Public: 10884521066960
• 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): 02/23/2021

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: No Information
• Device Model Number: P4P16TSD
• Device Catalogue Number: P4P16TSD
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 01/22/2021
• Supplement Report FDA Received Date: 02/23/2021
• Patient Sequence Number: 1
• Patient Age: 45 YR