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)
Date of Event	06/05/2021
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 the foley separated from the drainage bag when the patient was sitting in a chair.The patient was a (b)(6) male cardiac surgery patient.The foley was inserted in the or and came apart in the csicu.There was no harm to the patient.
Additional Manufacturer Narrative
The device history record could not be performed because a lot number could not be provided by the customer.The manufacturing site received one sample with this customer report.A complete investigation was performed.A visual inspection to the quality inspection standard was conducted.The sample was received without the catheter, the adapter was observed without the catheter connection.The reported condition could not be confirmed because the catheter was not returned intact for evaluation.A corrective/preventative action (capa) was opened to address complaints of catheter detachment.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.

• 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: 11987041
• Report Number: 9612030-2021-02937
• Device Sequence Number: 3426441
• Product Code: FFG
• UDI-Device Identifier: 10884521066960
• UDI-Public: 10884521066960
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/02/2021

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?: Yes
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 06/11/2021
• Supplement Report FDA Received Date: 09/02/2021
• Patient Sequence Number: 1