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	03/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.The results will be forwarded upon completion.
Event or Problem Description
The customer reported that the foley spontaneously broke apart in the csicu, the catheter detached from the tubing at the green seal.There was no patient injury reported.No further information is available.
Additional Manufacturer Narrative
Additional information: h4 device manufacture date added h3 evaluation summary: one decontaminated drainage bag and 9 unused samples were received at the manufacturing site for evaluation.Visual and functional inspection of the nine samples was performed according to procedures.The reported condition could not be confirmed in the unused samples received.They are within the specifications according to the functional stress test that was carried out.As for the used sample, it was received with the catheter disconnected.The reported condition is confirmed; the catheter is detached from the adapter of the sampling port.Based on the functional tests performed to all 9 received samples, these were found meeting the quality specifications.Only one sample presented the reported condition, the catheter detached from the sampling port adapter.The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.A corrective and preventative action (capa) has been opened to investigate and address the reported condition.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: 11611261
• Report Number: 9612030-2021-02837
• Device Sequence Number: 17060597
• 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,health
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 08/23/2021
• Patient Sequence Number: 1